Publications by authors named "Philippe Thuillier"

41 Publications

Smoking and diabetes interplay: A comprehensive review and joint statement.

Diabetes Metab 2022 Jun 29;48(6):101370. Epub 2022 Jun 29.

Outpatient Addiction Center, Georges Pompidou European Hospital, AP-HP, Sorbonne Paris Cité, Paris, France.

Evidence shows that smoking increases the risk of pre-diabetes and diabetes in the general population. Among persons with diabetes, smoking has been found to increase the risk of all-cause mortality and aggravate chronic diabetic complications and glycemic control. The current paper, which is a joint position statement by the French-Speaking Society on Tobacco (Société Francophone de Tabacologie) and the French-Speaking Society of Diabetes (Société Francophone du Diabète), summarizes the data available on the association between smoking and diabetes and on the impact of smoking and smoking cessation among individuals with type 1, type 2, and gestational diabetes mellitus. It also provides evidence-based information about the pharmacological and behavioral strategies for smoking cessation in these patients.
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http://dx.doi.org/10.1016/j.diabet.2022.101370DOI Listing
June 2022

Differences in perceived clinical knowledge uptake among health profession students and licensed clinicians receiving buprenorphine waiver training in Oregon.

Subst Abus 2022 ;43(1):825-833

Department of Family Medicine, School of Medicine, Oregon Health & Science University, Portland, OR, USA.

Addressing the opioid crisis requires an understanding of how to train both health professional students and practicing clinicians on medications for opioid use disorder (mOUD). We designed a robust evaluation instrument to assess the impact of training on perceived clinical knowledge in these different categories of learners. We enrolled 3rd and 4th year medical, physician assistant (PA), and nurse practitioner (NP) students, as well as practicing PAs, NPs, and physicians to undertake the Drug Addiction Treatment Act (DATA) Waiver Training for mOUD. We designed and implemented a cross-sectional survey to assess perceived change in clinical knowledge as a result of training in opioid use disorder and satisfaction with training. Twenty-one MD/DO and 45 NP/PA students, and 24 practicing MD/DO and 27 NP/PAs completed the survey. Among health professional students ( = 66) and practicing clinicians ( =51), perceived clinical knowledge scores increased significantly ( < 0.001) for all 13 variables. Program evaluation scores for the buprenorphine waiver training were high with no statistical differences between students and practicing clinicians. Overall, the majority of participants indicated they would recommend the training to a colleague (Students' score = 4.84; practicing clinician scores = 4.53; scale = strongly disagree = 1 to strongly agree = 5). Our novel instrument allowed us to determine that the implementation of buprenorphine waiver trainings for health professional students and practicing clinicians leads to significant increases in perceived knowledge, interest and confidence in diagnosing and treating OUD. Although the buprenorphine waiver can now be obtained without training, many waivered providers still do not prescribe buprenorphine; integrating training into medical, NP, and PA curriculum for students and offering the training to practicing clinicians may increase confidence and uptake of mOUD.
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http://dx.doi.org/10.1080/08897077.2021.2010260DOI Listing
April 2022

Prevention of exercise-induced hypoglycemia in 12 patients with type 1 diabetes running the Paris Marathon using continuous glucose monitoring: A prospective, single-center observational study.

Diabetes Metab 2022 Mar 12;48(2):101321. Epub 2022 Jan 12.

Department of Endocrinology, University Hospital of Brest, France; EA GETBO 3878, University Hospital of Brest, France.

Objective: To investigate the glycemic balance before, during and after the 2016 Paris Marathon using a real-time continuous glucose monitoring (RT-CGM) system in patients with type 1 diabetes mellitus in a prospective single-center observational study.

Methods: Inclusion criteria were as follows: type 1 diabetes mellitus; age ≥18 years; HbA1c < 9%. Participants performed two 2h-preparatory races (PR) before the Marathon and were monitored with RT-CGM 24h before, during and 72h after each race. Hypoglycemic events were prevented via carbohydrate intake / insulin dose adjustments. The primary outcome was area under the curve (AUC) < 70 and > 200 mg/dl and percentage of time spent in euglycemia, hypoglycemia, and hyperglycemia during the races.

Results: Twelve patients (2F/10M; median HbA1c=6.8%) were included and completed the study. Median AUC < 70 and time spent in hypoglycemia (< 70 mg/dl) during the PRs and Marathon were equal to 0. However, no hypoglycemic episodes occurred during Marathon, while two patients experienced hypoglycemia during PR1 and PR2. There was a significant increase in AUC > 200 mg/dl during races between PR2 and Marathon (P = 0.009) although the median time spent > 200mg/dl was not statistically different in Marathon versus PR2 (48.4% versus 18.4%; P = 0.09). Median time spent in euglycemia (70-200 mg/dl) was lower in Marathon versus PR2 (51.6 versus 58%; P = 0.03).

Conclusion: Our study proposes a medical support protocol for extreme endurance physical activity in patients with type 1 diabetes mellitus. Our results suggest that RT-CGM, coupled with adjustments in carbohydrate intake and insulin doses, appears to be effective to prevent hypoglycemia during and after exercise.
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http://dx.doi.org/10.1016/j.diabet.2022.101321DOI Listing
March 2022

Prognostic Value of Whole-Body PET Volumetric Parameters Extracted from Ga-DOTATOC PET/CT in Well-Differentiated Neuroendocrine Tumors.

J Nucl Med 2022 07 5;63(7):1014-1020. Epub 2021 Nov 5.

Nuclear Medicine Unit, Department of Medical Sciences, University of Turin, Turin, Italy.

Our objective was to evaluate the prognostic value of somatostatin receptor tumor burden on Ga-DOTATOC PET/CT in patients with well-differentiated (WD) neuroendocrine tumors (NETs). We retrospectively analyzed the Ga-DOTATOC PET/CT scans of 84 patients with histologically confirmed WD NETs (51 grade 1, 30 grade 2, and 3 grade 3). For each PET/CT scan, all Ga-DOTATOC-avid lesions were independently segmented by 2 operators using a customized threshold based on the healthy liver SUV (LIFEx, version 5.1). Somatostatin receptor-expressing tumor volume (SRETV) and total lesion somatostatin receptor expression (TLSRE = SRETV × SUV) were extracted for each lesion, and then whole-body SRETV and TLSRE (SRETVwb and TLSREwb, respectively) were defined as the sum of SRETV and TLSRE, respectively, for all segmented lesions in each patient. Time to progression (TTP) was defined as the combination of disease-free survival in patients undergoing curative surgery ( = 10) and progression-free survival for patients with unresectable or metastatic disease ( = 74). TTP and overall survival were calculated by Kaplan-Meier analysis, log-rank testing, and the Cox proportional-hazards regression model. After a median follow-up of 15.5 mo, disease progression was confirmed in 35 patients (41.7%) and 14 patients died. A higher SRETVwb (>39.1 cm) and TLSREwb (>306.8 g) correlated significantly with a shorter median TTP (12 mo vs. not reached; < 0.001). In multivariate analysis, SRETVwb ( = 0.005) was the only independent predictor of TTP regardless of histopathologic grade and TNM staging. According to our results, SRETVwb and TLSREwb extracted from Ga-DOTATOC PET/CT could predict TTP or overall survival and might have important clinical utility in the management of patients with WD NETs.
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http://dx.doi.org/10.2967/jnumed.121.262652DOI Listing
July 2022

Sex disparities in COVID-19 outcomes of inpatients with diabetes: insights from the CORONADO study.

Eur J Endocrinol 2021 Jul 5;185(2):299-311. Epub 2021 Jul 5.

Department of Endocrinology, Diabetology and Nutrition, Strasbourg University Hospitals, Strasbourg, France.

Objective: Male sex is one of the determinants of severe coronavirus diseas-e-2019 (COVID-19). We aimed to characterize sex differences in severe outcomes in adults with diabetes hospitalized for COVID-19.

Methods: We performed a sex-stratified analysis of clinical and biological features and outcomes (i.e. invasive mechanical ventilation (IMV), death, intensive care unit (ICU) admission and home discharge at day 7 (D7) or day 28 (D28)) in 2380 patients with diabetes hospitalized for COVID-19 and included in the nationwide CORONADO observational study (NCT04324736).

Results: The study population was predominantly male (63.5%). After multiple adjustments, female sex was negatively associated with the primary outcome (IMV and/or death, OR: 0.66 (0.49-0.88)), death (OR: 0.49 (0.30-0.79)) and ICU admission (OR: 0.57 (0.43-0.77)) at D7 but only with ICU admission (OR: 0.58 (0.43-0.77)) at D28. Older age and a history of microvascular complications were predictors of death at D28 in both sexes, while chronic obstructive pulmonary disease (COPD) was predictive of death in women only. At admission, C-reactive protein (CRP), aspartate amino transferase (AST) and estimated glomerular filtration rate (eGFR), according to the CKD-EPI formula predicted death in both sexes. Lymphocytopenia was an independent predictor of death in women only, while thrombocytopenia and elevated plasma glucose concentration were predictors of death in men only.

Conclusions: In patients with diabetes admitted for COVID-19, female sex was associated with lower incidence of early severe outcomes, but did not influence the overall in-hospital mortality, suggesting that diabetes mitigates the female protection from COVID-19 severity. Sex-associated biological determinants may be useful to optimize COVID-19 prevention and management in women and men.
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http://dx.doi.org/10.1530/EJE-21-0068DOI Listing
July 2021

Incidental Finding of a Parotid Basal Cell Adenoma With High Tracer Uptake on 68Ga-DOTATOC PET/CT.

Clin Nucl Med 2021 Jul;46(7):e381-e383

Oto-Rhino-Laryngology Department, University Hospital Morvan.

Abstract: A 67-year-old man was referred to our department to undergo a 68Ga-DOTATOC PET/CT during the systematic follow-up of a small intestine neuroendocrine tumor. PET revealed an incidental focal increased uptake of 68Ga-DOTATOC matching with a left intraparotid lesion on the combined contrast-enhanced CT, suggestive of a benign salivary tumor. An MRI was performed to characterize this lesion, and finally, the patient underwent surgery. Histological analysis confirmed the presence of a basal cell adenoma.
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http://dx.doi.org/10.1097/RLU.0000000000003564DOI Listing
July 2021

Diagnostic Value of Conventional PET Parameters and Radiomic Features Extracted from 18F-FDG-PET/CT for Histologic Subtype Classification and Characterization of Lung Neuroendocrine Neoplasms.

Biomedicines 2021 Mar 10;9(3). Epub 2021 Mar 10.

Nuclear Medicine Unit, Department of Medical Sciences, University of Turin, 10126 Turin, Italy.

Aim: To evaluate if conventional Positron emission tomography (PET) parameters and radiomic features (RFs) extracted by 18F-FDG-PET/CT can differentiate among different histological subtypes of lung neuroendocrine neoplasms (Lu-NENs).

Methods: Forty-four naïve-treatment patients on whom 18F-FDG-PET/CT was performed for histologically confirmed Lu-NEN (n = 46) were retrospectively included. Manual segmentation was performed by two operators allowing for extraction of four conventional PET parameters (SUVmax, SUVmean, metabolic tumor volume (MTV), and total lesion glycolysis (TLG)) and 41 RFs. Lu-NENs were classified into two groups: lung neuroendocrine tumors (Lu-NETs) vs. lung neuroendocrine carcinomas (Lu-NECs). Lu-NETs were classified according to histological subtypes (typical (TC)/atypical carcinoid (AC)), Ki67-level, and TNM staging. The least absolute shrink age and selection operator (LASSO) method was used to select the most predictive RFs for classification and Pearson correlation analysis was performed between conventional PET parameters and selected RFs.

Results: PET parameters, in particular, SUVmax (area under the curve (AUC) = 0.91; cut-off = 5.16) were higher in Lu-NECs vs. Lu-NETs ( < 0.001). Among RFs, HISTO_Entropy_log10 was the most predictive (AUC = 0.90), but correlated with SUVmax/SUVmean (r = 0.95/r = 0.94, respectively). No statistical differences were found between conventional PET parameters and RFs ( > 0.05) and TC vs. AC classification. Conventional PET parameters were correlated with N+ status in Lu-NETs.

Conclusion: In our study, conventional PET parameters were able to distinguish Lu-NECs from Lu-NETs, but not TC from AC. RFs did not provide additional information.
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http://dx.doi.org/10.3390/biomedicines9030281DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8001140PMC
March 2021

Prospective study of dynamic whole-body 68Ga-DOTATOC-PET/CT acquisition in patients with well-differentiated neuroendocrine tumors.

Sci Rep 2021 03 1;11(1):4727. Epub 2021 Mar 1.

EA GETBO 3878, University Hospital of Brest, Brest, France.

To present the feasibility of a dynamic whole-body (DWB) Ga-DOTATOC-PET/CT acquisition in patients with well-differentiated neuroendocrine tumors (WD-NETs). Sixty-one patients who underwent a DWB Ga-DOTATOC-PET/CT for a histologically proven/highly suspected WD-NET were prospectively included. The acquisition consisted in single-bed dynamic acquisition centered on the heart, followed by the DWB and static acquisitions. For liver, spleen and tumor (1-5/patient), Ki values (in ml/min/100 ml) were calculated according to Patlak's analysis and tumor-to-liver (TLR-Ki) and tumor-to-spleen ratios (TSR-Ki) were recorded. Ki-based parameters were compared to static parameters (SUVmax/SUVmean, TLR/TSRmean, according to liver/spleen SUVmean), in the whole-cohort and according to the PET system (analog/digital). A correlation analysis between SUVmean/Ki was performed using linear and non-linear regressions. Ki-liver was not influenced by the PET system used, unlike SUVmax/SUVmean. The regression analysis showed a non-linear relation between Ki/SUVmean (R = 0.55,0.68 and 0.71 for liver, spleen and tumor uptake, respectively) and a linear relation between TLRmean/TLR-Ki (R = 0.75). These results were not affected by the PET system, on the contrary of the relation between TSRmean/TSR-Ki (R = 0.94 and 0.73 using linear and non-linear regressions in digital and analog systems, respectively). Our study is the first showing the feasibility of a DWB Ga-DOTATOC-PET/CT acquisition in WD-NETs.
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http://dx.doi.org/10.1038/s41598-021-83965-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7921579PMC
March 2021

Impact of segmentation and discretization on radiomic features in Ga-DOTA-TOC PET/CT images of neuroendocrine tumor.

EJNMMI Phys 2021 Feb 27;8(1):21. Epub 2021 Feb 27.

Nuclear Medicine Unit, Department of Medical Sciences, University of Turin, Corso Dogliotti 14, 10126, Turin, Italy.

Objective: To identify the impact of segmentation methods and intensity discretization on radiomic features (RFs) extraction from Ga-DOTA-TOC PET images in patients with neuroendocrine tumors.

Methods: Forty-nine patients were retrospectively analyzed. Tumor contouring was performed manually by four different operators and with a semi-automatic edge-based segmentation (SAEB) algorithm. Three SUV fixed thresholds (20, 30, 40%) were applied. Fifty-one RFs were extracted applying two different intensity rescale factors for gray-level discretization: one absolute (AR60 = SUV from 0 to 60) and one relative (RR = min-max of the VOI SUV). Dice similarity coefficient (DSC) was calculated to quantify segmentation agreement between different segmentation methods. The impact of segmentation and discretization on RFs was assessed by intra-class correlation coefficients (ICC) and the coefficient of variance (COV). The RFs' correlation with volume and SUV was analyzed by calculating Pearson's correlation coefficients.

Results: DSC mean value was 0.75 ± 0.11 (0.45-0.92) between SAEB and operators and 0.78 ± 0.09 (0.36-0.97), among the four manual segmentations. The study showed high robustness (ICC > 0.9): (a) in 64.7% of RFs for segmentation methods using AR60, improved by applying SUV threshold of 40% (86.5%); (b) in 50.9% of RFs for different SUV thresholds using AR60; and (c) in 37% of RFs for discretization settings using different segmentation methods. Several RFs were not correlated with volume and SUV.

Conclusions: RFs robustness to manual segmentation resulted higher in NET Ga-DOTA-TOC images compared to F-FDG PET/CT images. Forty percent SUV thresholds yield superior RFs stability among operators, however leading to a possible loss of biological information. SAEB segmentation appears to be an optimal alternative to manual segmentation, but further validations are needed. Finally, discretization settings highly impacted on RFs robustness and should always be stated.
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http://dx.doi.org/10.1186/s40658-021-00367-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7914329PMC
February 2021

Ga-DOTATOC PET/CT-Based Radiomic Analysis and PRRT Outcome: A Preliminary Evaluation Based on an Exploratory Radiomic Analysis on Two Patients.

Front Med (Lausanne) 2020 26;7:601853. Epub 2021 Jan 26.

Nuclear Medicine Unit, Department of Medical Sciences, University of Turin, Turin, Italy.

This work aims to evaluate whether the radiomic features extracted by 68Ga-DOTATOC-PET/CT of two patients are associated with the response to peptide receptor radionuclide therapy (PRRT) in patients affected by neuroendocrine tumor (NET). This is a pilot report in two NET patients who experienced a discordant response to PRRT (responder vs. non-responder) according to RECIST1.1. The patients presented with liver metastasis from the rectum and pancreas G3-NET, respectively. Whole-body total-lesion somatostatin receptor-expression (TLSREwb-50) and somatostatin receptor-expressing tumor volume (SRETV wb-50) were obtained in pre- and post-PRRT PET/CT. Radiomic analysis was performed, extracting 38 radiomic features (RFs) from the patients' lesions. The Mann-Whitney test was used to compare RFs in the responder patient vs. the non-responder patient. Pearson correlation and principal component analysis (PCA) were used to evaluate the correlation and independence of the different RFs. TLSREwb-50 and SRETVwb-50 modifications correlate with RECIST1.1 response. A total of 28 RFs extracted on pre-therapy PET/CT showed significant differences between the two patients in the Mann-Whitney test ( < 0.05). A total of seven second-order features, with poor correlation with SUVmax and PET volume, were identified by the Pearson correlation matrix. Finally, the first two PCA principal components explain 83.8% of total variance. TLSREwb-50 and SRETVwb-50 are parameters that might be used to predict and to assess the PET response to PRRT. RFs might have a role in defining inter-patient heterogeneity and in the prediction of therapy response. It is important to implement future studies with larger and more homogeneous patient populations to confirm the efficacy of these biomarkers.
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http://dx.doi.org/10.3389/fmed.2020.601853DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7870479PMC
January 2021

Thyroid dysfunction induced by immune checkpoint inhibitors is associated with a better progression-free survival and overall survival in non-small cell lung cancer: an original cohort study.

Cancer Immunol Immunother 2021 Jul 9;70(7):2023-2033. Epub 2021 Jan 9.

Department of Endocrinology, University Hospital of Brest, Boulevard Tanguy Prigent, 29609, Brest Cedex, France.

Background: The objective of this study was to investigate the association between the onset of TD and treatment efficacy in NSCLC patients who initiated anti-PD-1 blockade (Nivolumab) and to assess the impact of TD severity and subtype on nivolumab efficacy.

Materials And Methods: This study was performed at a referral oncology center between July 20, 2015 and June 30, 2018. Patients with histologically confirmed stage IIIB/IV NSCLC in progression after one or two lines of treatment and who initiated Nivolumab were included. Thyroid function (TSH ± fT4, fT3) was monitored and patients were classified according to TD status [TD(+) versus TD(-)], severity [moderate thyroid dysfunction: TSH level between 0.1 and 0.4 or 4.0 and 10 mIU/L and severe thyroid dysfunction: TSH ≤ 0.1 or ≥ 10mUI/L) and subtype (isolated hypothyroidism, isolated hyperthyroidism and hyperthyroidism then hypothyroidism)]. Clinical endpoints were overall survival (OS) and progression-free survival (PFS).

Results: Among 194 eligible patients, 134 patients (median age, 63 yo; 70.1% male) were included. Forty (29.9%) patients were classified in TD(+) and had a longer OS of 29.8 months (95% CI 18.8-NR) versus 8.1 months (95% CI 5.5-11.5) in TD(-) group (p < 0.001). PFS was also longer (8.7 months (95% CI 5.3-15.1) in TD(+) versus 1.7 months (95% CI 1.6-1.9) in TD(-) group (p < 0.001). In Cox proportional hazards analysis, TD remained an independent predictive factor of OS/PFS. Severity and subtype of TD were not correlated with OS/PFS.

Conclusions: This study suggested that TD induced by Nivolumab appears to be an independent predictive factor of survival, irrespective of TD severity and subtype.
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http://dx.doi.org/10.1007/s00262-020-02802-6DOI Listing
July 2021

The Challenge of Evaluating Response to Peptide Receptor Radionuclide Therapy in Gastroenteropancreatic Neuroendocrine Tumors: The Present and the Future.

Diagnostics (Basel) 2020 Dec 12;10(12). Epub 2020 Dec 12.

Nuclear Medicine Unit, Department of Medical Sciences, University of Turin, 10126 Turin, Italy.

The NETTER-1 study has proven peptide receptor radionuclide therapy (PRRT) to be one of the most effective therapeutic options for metastatic neuroendocrine tumors (NETs), improving progression-free survival and overall survival. However, PRRT response assessment is challenging and no consensus on methods and timing has yet been reached among experts in the field. This issue is owed to the suboptimal sensitivity and specificity of clinical biomarkers, limitations of morphological response criteria in slowly growing tumors and necrotic changes after therapy, a lack of standardized parameters and timing of functional imaging and the heterogeneity of PRRT protocols in the literature. The aim of this article is to review the most relevant current approaches for PRRT efficacy prediction and response assessment criteria in order to provide an overview of suitable tools for safe and efficacious PRRT.
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http://dx.doi.org/10.3390/diagnostics10121083DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7763988PMC
December 2020

Clinical Assessment of 177Lu-DOTATATE Quantification by Comparison of SUV-Based Parameters Measured on Both Post-PRRT SPECT/CT and 68Ga-DOTATOC PET/CT in Patients With Neuroendocrine Tumors: A Feasibility Study.

Clin Nucl Med 2021 Feb;46(2):111-118

Department of Oncology, University Hospital of Brest, Brest, France.

Patients And Methods: Patients with WD-GEP-NET who benefited from a pretherapeutic 68Ga-DOTATOC PET/CT and a 177Lu-DOTATATE SPECT/CT after the cycle 1 of peptide receptor radionuclide therapy were prospectively included. SPECT/CT acquisitions were performed on a system calibrated with a conversion factor of 9.48 counts/MBq per second and were reconstructed with an iterative algorithm allowing quantification using the SPECTRA Quant software (MIM Software, Cleveland, OH). For each patient, different SUV parameters were recorded on both PET/CT (Ga parameters) and SPECT/CT (Lu parameters) for comparison: physiological uptakes (liver/spleen), tumor uptake (1-10/patient; SUVmax, SUVmean, SUVpeak, MTV), tumor-to-liver and tumor-to-spleen ratios according to liver/spleen SUVmax and SUVmean (TLRmax, TLRmean, TSRmax, and TSRmean, respectively).

Results: Ten patients (8 female; 2 male) aged from 50 to 83 years presenting with a metastatic progressive WD-GEP-NET (7 small intestine, 2 pancreas, 1 rectum) were included. Median values of lesional Lu-SUV were significantly lower than the corresponding Ga-SUV (P < 0.001), whereas median values of lesional Lu-MTV, Lu-TLR, and Lu-TSR were significantly higher than the corresponding Ga-MTV, Ga-TLR, and Ga-TSR (P < 0.02). Pearson correlation coefficients were strong for both SUV and MTV parameters (0.779-0.845), weak for TLR parameters (0.365-0.394), and moderate-to-strong for TSR parameters (0.676-0.750).

Conclusions: Our results suggest the feasibility of 177Lu-DOTATATE SPECT/CT quantification in clinical practice and show a strong correlation of several SUV-based parameters with the corresponding in 68Ga-DOTATOC PET/CT.
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http://dx.doi.org/10.1097/RLU.0000000000003412DOI Listing
February 2021

Diagnostic performance of a whole-body dynamic 68GA-DOTATOC PET/CT acquisition to differentiate physiological uptake of pancreatic uncinate process from pancreatic neuroendocrine tumor.

Medicine (Baltimore) 2020 Aug;99(33):e20021

EA GETBO 3878.

To evaluate the diagnostic performance of net influx rate (Ki) values from a whole-body dynamic (WBD) Ga-DOTATOC-PET/CT acquisition to differentiate pancreatic neuroendocrine tumors (pNETs) from physiological uptake of pancreatic uncinate process (UP).Patients who were benefited from a WBD acquisition for the assessment of a known well-differentiated neuroendocrine tumor (NET)/suspicion of disease in the prospective GAPET-NET cohort were screened. Only patients with a confirmed pNET/UP as our gold standard were included. The positron emission tomography (PET) procedure consisted in a single-bed dynamic acquisition centered on the heart, followed by a whole-body dynamic acquisition and then a static acquisition. Dynamic (Ki calculated according to Patlak method), static (SUVmax, SUVmean, SUVpeak) parameters, and tumor-to-liver and tumor-to-spleen ratio (TLRKi and TSRKi (according to hepatic/splenic Ki)), tumor SUVmax to liver SUVmax (TM/LM), tumor SUVmax to liver SUVmean (TM/Lm), tumor SUVmax to spleen SUVmax (TM/SM), and tumor SUVmax to spleen SUVmean (TM/Sm) (according to hepatic/splenic SUVmax and SUVmean respectively) were calculated. A Receiver Operating Characteristic (ROC) analysis was performed to evaluate their diagnostic performance to distinguish UP from pNET.One hundred five patients benefited from a WBD between July 2018 and July 2019. Eighteen (17.1%) had an UP and 26 (24.8%) a pNET. For parameters alone, the Ki and SUVpeak had the best sensitivity (88.5%) while the Ki, SUVmax, and SUVmean had the best specificity (94.4%). The best diagnostic accuracy was obtained with Ki (90.9%). For ratios, the TLRKi and the TSRKi had the best sensitivity (95.7%) while the TM/SM and TM/Sm the best specificity (100%). TLRKi had the best diagnostic accuracy (95.1%) and the best area under the curve (AUC) (0.990).Our study is the first one to evaluate the interest of a WBD acquisition to differentiate UP from pNETs and shows excellent diagnostic performances of the Ki approach.
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http://dx.doi.org/10.1097/MD.0000000000020021DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7437793PMC
August 2020

Development and evaluation of a simulation-based transition to clerkship course.

Perspect Med Educ 2020 12;9(6):379-384

Departments of Behavioral Neuroscience, Psychiatry and the Oregon Institute of Occupational Health Sciences, Oregon Health & Science University, Portland, OR, USA.

Background: Transition to clerkship courses bridge the curricular gap between preclinical and clinical medical education. However, despite the use of simulation-based teaching techniques in other aspects of medical training, these techniques have not been adequately described in transition courses. We describe the development, structure and evaluation of a simulation-based transition to clerkship course.

Approach: Beginning in 2012, our institution embarked upon an extensive curricular transformation geared toward competency-based education. As part of this effort, a group of 12 educators designed, developed and implemented a simulation-based transition course. The course curriculum involved seven goals, centered around the 13 Association of American Medical Colleges Core Entrustable Professional Activities for entering residency. Instructional techniques included high-fidelity simulation, and small and large group didactics. Student competency was determined through a simulation-based inpatient-outpatient objective structured clinical examination, with real-time feedback and remediation. The effectiveness of the course was assessed through a mixed methods approach involving pre- and post-course surveys and a focus group.

Evaluation: Of 166 students, 152 (91.6%) completed both pre- and post-course surveys, and nine students participated in the focus group. Students reported significant improvements in 21 out of 22 course objectives. Qualitative analysis revealed three key themes: learning environment, faculty engagement and collegiality. The main challenge to executing the course was procuring adequate faculty, material and facility resources.

Reflection: This simulation-based, resource-heavy transition course achieved its educational objectives and provided a safe, supportive learning environment for practicing and refining clinical skills.
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http://dx.doi.org/10.1007/s40037-020-00590-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7718359PMC
December 2020

Comparison of the New, Rapid, and Fully Automated Kryptor TSH receptor Antibodies Assay (B.R.A.H.M.S.) with the Radioimmunological Assay (B.R.A.H.M.S.).

Clin Lab 2019 Nov;65(11)

Background: Radioimmunoassays, which are often not automated and time-consuming, are gradually being re-placed in medical laboratories by non-radioactive methods that need to be evaluated. The purpose was to compare the measurement of thyroid-stimulating hormone receptor antibodies (TRAb) by the new Brahms' kit using Kryptor TRACE technology and the Brahms' radioimmunoassay.

Methods: We prospectively collected all samples from patients who received thyroid-stimulating hormone receptor antibodies testing in July 2018 at the University Hospital of Brest. The radioimmunoassay used was the Dynotest TRAK human by BRAHMS Diagnostica (Berlin, Germany). The Kryptor method used the BRAHMS TRAK human Kryptor kit performed with the Kryptor Compact Plus system.

Results: The inter-assay coefficient variations for the radioimmunological and Kryptor methods were 11.07% and 8.36%, respectively, with the low level quality control and 8.36% and 4.38%, respectively, with the high level quality control. Forty-four patients were included in the study including thirty-two Graves' disease patients in follow-up. The sensitivity of the radioimmunological method for the detection of Graves' disease was 0.94 and the specificity was 0.73. The sensitivity of the Kryptor method was 0.91 and the specificity was 0.91. A non-proportional systematic bias in favor of higher values of TRAb concentrations with the radioimmunological method was observed: slope of 0.93 (0.74 - 1.07, 95% confidence interval) and an intercept of -0.69 IU/L (-1.58 to -0.30, 95% confidence interval). Compared to the Kryptor method, the radioimmunological method tends to overestimate TRAb concentrations by up to 120%.

Conclusions: The fully automated Brahms Kryptor kit using TRACE technology to measure TRAb reduces sampling time and intra- as well as inter-assay variations. The Kryptor kit underestimates the results of TRAb leading to a lower sensitivity and higher specificity compared to the radioimmunoassay. Thus, the new Brahms Kryptor kit has good laboratory performances but the interpretation of the results must still be performed with caution.
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http://dx.doi.org/10.7754/Clin.Lab.2019.190124DOI Listing
November 2019

Polymorphisms in oxidative stress pathway genes and prostate cancer risk.

Cancer Causes Control 2019 Dec 30;30(12):1365-1375. Epub 2019 Oct 30.

OHSU-PSU School of Public Health, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Mail Code CR 145, Portland, OR, 97239, USA.

Purpose: Age-related factors including oxidative stress play an important role in prostate carcinogenesis. We hypothesize that germline single-nucleotide polymorphisms (SNPs) in oxidative stress pathway are associated with prostate cancer (PCa) risk. In this study, we aim to examine which of these SNPs is associated with PCa.

Methods: Participants included in this analyses came from the "Genetic Susceptibility, Environment and Prostate Cancer Risk Study" conducted at the Veterans Affairs Portland Health Care System. After applying exclusion criteria, 231 PCa cases and 382 prostate biopsy-negative controls who had genotyping data on twenty-two single-nucleotide polymorphisms (SNPs) in six genes (MAPK14, NRF2, CAT, GPX1, GSTP1, SOD2, and XDH) associated with oxidative stress pathway were included in the analyses. The genotyping of SNPs was conducted by the Illumina BeadXpress VeraCode platform. We investigated these SNPs in relation to overall and aggressive PCa risk using logistic regression models controlling for relevant covariates.

Results: One SNP in the MAPK14 (rs851023) was significantly associated with incident PCa risk. Compared to men carrying two copies of allele A, the presence of one or two copies of the G allele was associated with decreased risk of PCa [OR (95% CI) 0.19 (0.06-0.51)]. There was no statistically significant association between other SNPs in the NRF2, CAT, GPX1, GSTP1, SOD2, and XDH genes and PCa risk.

Conclusions: The MAPK14 gene SNP rs851023 was associated with PCa and aggressive PCa risk after multiple comparison adjustment. Further studies in other populations or functional studies are needed to validate the finding.
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http://dx.doi.org/10.1007/s10552-019-01242-7DOI Listing
December 2019

Diagnostic value of positron-emission tomography textural indices for malignancy of 18F-fluorodeoxyglucose-avid adrenal lesions.

Q J Nucl Med Mol Imaging 2021 Mar 25;65(1):79-87. Epub 2019 Mar 25.

EA GETBO 3878, University Hospital of Brest, Brest, France.

Background: PET Textural indices could have an add-on diagnostic value for diagnosis of malignancy in patients with FDG-avid adrenal lesions.

Methods: Consecutive patients referred for a FDG-PET/CT to our nuclear medicine department from June 2012 to June 2017 were retrospectively screened. Inclusion criteria were: patients with a FDG-avid adrenal lesion (uptake≥liver background); malignant/benign lesion confirmed histologically or with follow-up imaging examination. Pheochromocytomas were not included in the analysis. For each adrenal lesion, 5 quantitative PET parameters (SUVmax, MTV, TLG, TLRmax and TLRmean) were calculated. Thirty-seven textural indices were extracted using LIFEx software. Diagnostic performance to determine malignancy was assessed with a ROC analysis. Parameters with a significantly AUC>0.5 were selected and groups of highly correlated (r>0.8) parameters were created. A scoring system combining PET and textural indices was examined.

Results: PET textural indices were calculated for 53 lesions (37 malignant, 16 benign). Three PET metabolic parameters (SUVmax, TLRmax, TLRmean) and 13 textural indices had an AUC>0.5. Seven groups of highly correlated parameters (r>0.8) were extracted. For PET parameters, SUVmax had the best AUC (0.89 95% CI [0.79-0.98]; cut-off=7.0). For textural indices, ZLNU had the best AUC (0.87 95% CI [0.78-0.96]; cut-off=34.7) and specificity of 100%. Three scores combining the best four textural indices alone (ContrastGLCM, LRHGE, SZE and ZLNU) or with one PET parameters (SUVmax, TLRmax) were developed but did not increase the diagnostic performance (AUC≤0.89). ZLNU was the best parameter to distinguish primary adrenal cancer from adrenal metastases in malignant lesions (P<0.001).

Conclusions: Our study highlighted excellent diagnostic performance of several PET textural indices comparable to that of PET metabolic parameters. However, our results did not find any additional diagnostic value of textural indices when combined with metabolic parameters.
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http://dx.doi.org/10.23736/S1824-4785.19.03138-8DOI Listing
March 2021

Retroperitoneal Pelvic Solitary Fibrous Tumor With High Tracer Uptake in 68Ga-DOTATOC PET/CT: A Rare Differential Diagnosis of Paraganglioma.

Clin Nucl Med 2019 May;44(5):e370-e371

Nuclear Medicine, University Hospital of Brest, Brest, France.

We report the case of a 27-year-old woman referred to our department for the characterization of a 7 × 6-cm left ischio-anal fossa mass by Ga-DOTATOC PET/CT. Several diagnoses were previously mentioned, in particular, myxoid sarcoma but also pelvic paraganglioma. Urinary methoxylated derivates and blood chromogranin A tests were negative. PET/CT showed a high Ga-DOTATOC uptake of the mass that was strongly consistent with paraganglioma diagnosis. Histopathological analysis surprisingly revealed a solitary fibrous tumor without aggressive criteria.
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http://dx.doi.org/10.1097/RLU.0000000000002540DOI Listing
May 2019

Diagnostic Value of FDG PET-CT Quantitative Parameters and Deauville-Like 5 Point-Scale in Predicting Malignancy of Focal Thyroid Incidentaloma.

Front Med (Lausanne) 2019 12;6:24. Epub 2019 Feb 12.

EA GETBO 3878, University Hospital of Brest, Brest, France.

To evaluate the diagnostic value of FDG PET-CT metabolic parameters and Deauville-like 5 point-scale to predict malignancy in a population of patients presenting focal thyroid incidentaloma (fTI). This retrospective study included 41 fTI, classified according to cytological and histological data as benign (BL) or malignant lesion (ML). FDG PET-CT semi-quantitative parameters (SUVmax, SUVmean, SUVpeak, MTV, TLG), tumor to liver SUVmean ratio (TLRmax and TLRmean), tumor to blood-pool SUVmean ratio (TBRmax and TBRmean) were calculated. Each fTI was also classified on a Deauville-like 5-point scale (DS) currently used in lymphoma. Comparison between BL and ML was performed for each parameter and a ROC analysis was conducted. All quantitative PET metabolic parameters (SUV parameters, volume based parameters and SUV ratio) were higher in ML compared with BL, yet no significant difference was reported. fTI (uptake) malignancy rate according to DS grades 2, 3, 4, and 5 was, respectively, 25% (1 of 4), 28.6% (2 of 7), 8.3% (1 of 12), and 33.3% (6 of 18) with no significant difference between ML and BL groups. Results of ROC analysis showed that mean TBR had the highest AUC in our cohort (0.66 95%CI [0.41; 0.91]) with a cut-off value of 2.2. Specificity of MTV and TLG was 100% (cut-off values: MTV 9.6 ml, TLG 22.9 g) and their sensitivity was 30 and 40%, respectively. Our study did not highlight any FDG PET/CT parameter predictor of fTI malignancy.
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http://dx.doi.org/10.3389/fmed.2019.00024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6379284PMC
February 2019

[Biological diagnosis of pheochromocytoma: is there an interest in urinary metanephrines measurement over 3 consecutive days?]

Ann Biol Clin (Paris) 2018 10;76(5):537-544

Département de biochimie et pharmaco-toxicologie, Centre hospitalier régional universitaire de Brest, Brest, France, Laboratoire des interactions épithéliums neurones (LIEN), Université de Bretagne Occidentale (UBO), Brest, France.

Pheochromocytoma and paraganglioma are neuroendocrine tumors characterized by a catecholamine production potential. The biochemical diagnosis for this type of tumor is carried out through the metanephrine titration on 24-hours urines. Some authors have suggested that the sensitivity of the test could be improved by sampling and analyzing urines 3 days in a row (cycle) versus a unique measurement but this method has never been fully evaluated. The goal of this study was to establish a comparison of diagnosis performances between urinary metanephrines measurement for 3 consecutive days, and metanephrines measurement on a unique 24-hour sample. Patients of Brest Regional University Hospital whose 3-consecutive day 24-hour urine samples had been analyzed from January 2011 to May 2017 were included in this study. The primary endpoint was the comparison of diagnostic performances of urinary metanephrine titration over a single day versus 3 consecutive days. Eighty-two patients for a total of 103 cycles among which 7 revealed a pheochromocytoma were analyzed. ROC curve analysis shows that the metanephrine cycle titration method is more efficient than the metanephrine single titration method (metanephrine: AUC=0.881 against 0.826 respectively; normetanephrine: AUC=0.946 against 0.901 respectively). Urinary titration over 3 days allows the diagnosis of 100% (7/7) of pheochromocytomas against 85.7% (6/7) for the the single urinary titration. In conclusion, metanephrine titration over 3 consecutive days of 24-hours urine samples shows a better sensitivity and better diagnosis performances for detecting pheochromocytoma and paraganglioma than the single titration method.
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http://dx.doi.org/10.1684/abc.2018.1377DOI Listing
October 2018

Broccoli Sprouts Delay Prostate Cancer Formation and Decrease Prostate Cancer Severity with a Concurrent Decrease in HDAC3 Protein Expression in Transgenic Adenocarcinoma of the Mouse Prostate (TRAMP) Mice.

Curr Dev Nutr 2018 Mar 26;2(3):nzy002. Epub 2017 Dec 26.

School of Biological and Population Health Sciences, Oregon State University, Corvallis, OR.

Background: Cruciferous vegetables have been associated with the chemoprevention of cancer. Epigenetic regulators have been identified as important targets for prostate cancer chemoprevention. Treatment of human prostate cancer cells with sulforaphane (SFN), a chemical from broccoli and broccoli sprouts, inhibits epigenetic regulators such as histone deacetylase (HDAC) enzymes, but it is not known whether consumption of a diet high in broccoli sprouts impacts epigenetic mechanisms in an in vivo model of prostate cancer.

Objective: In the transgenic adenocarcinoma of the mouse prostate (TRAMP) model, we tested the hypothesis that a broccoli sprout diet suppresses prostate cancer, inhibits HDAC expression, alters histone modifications, and changes the expression of genes regulated by HDACs.

Methods: TRAMP mice were fed a 15% broccoli sprout or control AIN93G diet; tissue samples were collected at 12 and 28 wk of age.

Results: Mice fed broccoli sprouts had detectable amounts of SFN metabolites in liver, kidney, colon, and prostate tissues. Broccoli sprouts reduced prostate cancer incidence and progression to invasive cancer by 11- and 2.4-fold at 12 and 28 wk of age, respectively. There was a significant decline in HDAC3 protein expression in the epithelial cells of prostate ventral and anterior lobes at age 12 wk. Broccoli sprout consumption also decreased histone H3 lysine 9 trimethylation in the ventral lobe (age 12 wk), and decreased histone H3 lysine 18 acetylation in all prostate lobes (age 28 wk). A decline in mRNA levels, a gene regulated by HDAC3, was associated with broccoli sprout consumption, but no significant changes were noted at the protein level.

Conclusions: Broccoli sprout intake was associated with a decline in prostate cancer occurrence and HDAC3 protein expression in the prostate, extending prior work that implicated loss of HDAC3/ corepressor interactions as a key preventive mechanism by SFN in vivo.
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http://dx.doi.org/10.1093/cdn/nzy002DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6041877PMC
March 2018

Progression of Focal to Diffuse Thyroid Uptake Detected by 18F-FDG PET/CT: Malignant Metastatic Disease or Benign Thyroiditis?

Clin Nucl Med 2018 Sep;43(9):e310-e311

Departments of Oncology and.

A 49-year-old man was referred to our department for an assessment of a cerebral metastasis of unknown primary with F-FDG PET/CT. This imaging led to detection of a suspected pulmonary primary carcinoma, as well as an incidental left focal thyroid uptake. An ultrasonography, performed a month later, revealed a thyroiditis aspect. An anti-PD1 immunotherapy was also proposed 2 months later after confirmation of a lung adenocarcinoma. A second baseline FDG PET/CT surprisingly showed a diffuse thyroid uptake. A fine-needle aspiration biopsy of thyroid parenchyma finally revealed a diffuse involvement from lung adenocarcinoma (ie, primary lung metastasis to the thyroid gland).
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http://dx.doi.org/10.1097/RLU.0000000000002168DOI Listing
September 2018

Comparison between preprandial vs. postprandial insulin aspart in patients with type 1 diabetes on insulin pump and real-time continuous glucose monitoring.

Diabetes Metab Res Rev 2018 09 1;34(6):e3019. Epub 2018 Jun 1.

Department of Endocrinology, Diabetology and Metabolic Diseases, Medical University Hospital of BREST, BREST Cedex, France.

Background: The objective was to compare glycemic control between preprandial and postprandial bolus administration (15 min before [PRE] or immediately after the meal [POST]) in patients with type 1 diabetes using insulin pump and real-time continuous glucose monitoring.

Methods: Between September 2015 and February 2016, a single-centre, open randomized, 2-way crossover study of patients on bolus insulin aspart administration was conducted during two 14-day periods and according to 2 administration regimen schedules (PRE/POST or POST/PRE). Inclusion criteria were as follows: patients with type 1 diabetes, ≥18 and ≤ 65 years old, treated with insulin aspart using a Medtronic® insulin pump and trained on functional insulin therapy. Patients were randomly assigned to either regimen schedule. At the beginning of each period, each patient was provided with a standardized high fat meal. Primary outcome was the area under the curve for interstitial glucose above 140 mg/dL per minute (AUC > 140 mg/dL/min) during each period. Secondary outcomes were time spent in hypo/eu/hyperglycemia, glycemic variability indices, and AUC during 4 hours after high fat meal calculated with continuous glucose monitoring data.

Results: Twenty-two patients were included. Mean AUC > 140 mg/dL/min was statistically higher in patients on POST (43.70 mg/dL/min; 95%CI: 34.08 to 53.31) versus PRE insulin aspart regimen (37.24 mg/dL/min 95%CI: 27.63 to 46.85) (P = 0.03). Mean interstitial glycemia and glycemic variability indices were also increased (P < 0.05) on POST regimen. The mean AUC 4 hours after the high fat meal was higher on POST regimen but not statistically different (P = 0.06).

Conclusions: In our study, postprandial administration of insulin aspart appears to mildly increase glycemic excursion and glycemic variability.
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http://dx.doi.org/10.1002/dmrr.3019DOI Listing
September 2018

Clinical Validation of a Pixon-Based Reconstruction Method Allowing a Twofold Reduction in Planar Images Time of 111In-Pentetreotide Somatostatin Receptor Scintigraphy.

Front Med (Lausanne) 2017 30;4:143. Epub 2017 Aug 30.

Department of Nuclear Medicine, University Hospital of Brest, Brest, France.

Objective: The objective of this study was to evaluate the diagnostic efficacy of Pixon-based reconstruction method on planar somatostatin receptor scintigraphy (SRS).

Methods: All patients with neuroendocrine tumors (NETs) disease who were referred for SRS to our department during 1-year period from January to December 2015 were consecutively included. Three nuclear physicians independently reviewed all the data sets of images which included conventional images (CI; 15 min/view) and processed images (PI) obtained by reconstructing the first 450 s extracted data using Oncoflash software package. Image analysis using a 3-point rating scale for abnormal uptake of 111 Indium-DTPA-Phe-octreotide in any lesion or organ was interpreted as positive, uncertain, or negative for the evidence of NET disease. A maximum grade uptake of the radiotracer in the lesion was assessed by the Krenning scale method. The results of image interpretation by the two methods were considered significantly discordant when the difference in organ involvement assessment was negative vs. positive or in lesion uptake was ≥2 grades. Agreement between the results of two methods and by different scan observers was evaluated using Cohen κ coefficients.

Results: There was no significant ( = 0.403) correlation between data acquisition protocol and quality image. The rates of significant discrepancies for exam interpretation and organs involvement assessment were 2.8 and 2.6%, respectively. Mean κ values revealed a good agreement for concordance between CI and PI interpretation without difference of agreement for inter/intra-observer analysis.

Conclusion: Our results suggest the feasibility to use a Pixon-based reconstruction method for SRS planar images allowing a twofold reduction of acquisition time and without significant alteration of image quality or on image interpretation.
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http://dx.doi.org/10.3389/fmed.2017.00143DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5583596PMC
August 2017

Malignancy rate of focal thyroid incidentaloma detected by FDG PET-CT: results of a prospective cohort study.

Endocr Connect 2017 Aug 25;6(6):413-421. Epub 2017 Jun 25.

EA GETBO 3878University Hospital of Brest, Brest, France.

Objective: To evaluate the malignancy rate of focal thyroid incidentaloma (fTI) in a population of patients undergoing a 18F-fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET-CT) for a non-thyroid purpose.

Design: We conducted a prospective cohort study from January 2013 to November 2014. All consecutive patients referred for a FDG PET-CT were prospectively screened. Patients with known neoplastic thyroid disease were excluded from the analysis. All patients presenting one or more fTI and who accepted to benefit from a complementary thyroid ultrasonography (US) were included and managed according to the French endocrine society consensus. Prevalence of fTI in our population and malignancy rate was assessed.

Results: During the inclusion period, 10,171 patients were referred for a FDG PET-CT in our center. Fifty-three patients presenting a known thyroid disease were excluded. Among the remaining 10,118 patients, 127 (1.3%) with 131 fTI were individualized. US could not be performed in 37 patients. The remaining 90 patients (92 fTI) were explored by US ± fine-needle aspiration biopsy (FNAB). US results demonstrated a nodule aspect in 80 cases of which 60 benefited from FNAB. Nineteen of 92 fTI underwent surgery with 10 malignant lesions among the 60 patients performing both US and FNAB.

Conclusion: The prevalence of fTI discovered on FDG PET-CT in our population was 1.3% with 10 malignant lesions among the 60 patients performing both US and FNAB.
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http://dx.doi.org/10.1530/EC-17-0099DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5551426PMC
August 2017

Oral and vulvo-vaginal lichenoid reactions due to mitotane (Lysodren): A case report.

Medicine (Baltimore) 2017 Jan;96(2):e5075

aDepartment of Dental Surgery bDepartment of Endocrinology, Brest University Hospital, Brest cDepartment of Dermatology, Quimper Hospital, Quimper dDepartment of Oral Surgery, Brest University Hospital, Brest, France.

Background: The purpose of pharmacovigilance (drug safety) is collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. It is meant to identify, characterize, prevent, or minimize actual or potential risks relating to medicinal products. To prevent these adverse effects and improve our practice, health professionals have a duty to report side effects to assess this risk and evaluate the benefit/risk requirements. Mitotane (Lysodren) is used for treating adrenocortical carcinoma. Currently, no side effects concerning oral and genital mucosa have been reported.

Case Summary: This case report is about a 50 years old woman. Six months after the initiation on mitotane treatment, she developed erosive lesions located on the oral and vaginal mucosa. These drug reactions were diagnosed as erosive lichen planus by the biopsy. This lichenoid lesions were resistant to the usual treatments, mitotane being at the time not replaceable.

Conclusion: This case describes an unreported adverse effect of mitotane, it is - to our knowledge - the 1st description of erosive lichenoid drug reaction due to Mitotane.
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http://dx.doi.org/10.1097/MD.0000000000005075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5266149PMC
January 2017

Effects of ω-3 Fatty Acids and Catechins on Fatty Acid Synthase in the Prostate: A Randomized Controlled Trial.

Nutr Cancer 2016 Nov-Dec;68(8):1309-1319. Epub 2016 Sep 20.

a OHSU-PSU School of Public Health, Oregon Health and Science University , Portland , Oregon , USA.

Animal and human studies suggest fish oil and green tea may have protective effect on prostate cancer. Fatty acid synthase (FAS) has been hypothesized to be linked to chemoprotective effects of both compounds. This study evaluated the independent and joint effects of fish oil (FO) and green tea supplement (epigallocatechin-3-gallate, EGCG) on FAS and Ki-67 levels in prostate tissue. Through a double-blinded, randomized controlled trial with 2 × 2 factorial design, 89 men scheduled for repeat prostate biopsy following an initial negative prostate biopsy were randomized into either FO alone (1.9 g DHA + EPA/day), EGCG alone (600 mg/day), a combination of FO and EGCG, or placebo. We used linear mixed-effects models to test the differences of prostate tissue FAS and Ki-67 by immunohistochemistry between pre- and post-intervention within each group, as well as between treatment groups. Results did not show significant difference among treatment groups in pre-to-post-intervention changes of FAS (P = 0.69) or Ki-67 (P = 0.26). Comparing placebo group with any of the treatment groups, we did not find significant difference in FAS or Ki-67 changes (all P > 0.05). Results indicate FO or EGCG supplementation for a short duration may not be sufficient to produce biologically meaningful changes in FAS or Ki-67 levels in prostate tissue.
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http://dx.doi.org/10.1080/01635581.2016.1224365DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5154733PMC
December 2017

Sulforaphane Bioavailability and Chemopreventive Activity in Women Scheduled for Breast Biopsy.

Cancer Prev Res (Phila) 2015 Dec 28;8(12):1184-1191. Epub 2015 Oct 28.

School of Public Health, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239.

Epidemiologic studies suggest a protective effect of cruciferous vegetables on breast cancer. Sulforaphane (SFN), an active food component derived from crucifers, has been shown to be effective in breast cancer chemoprevention. This study evaluated the chemopreventive effect of SFN on selective biomarkers from blood and breast tissues. In a 2- to 8-week double-blinded, randomized controlled trial, 54 women with abnormal mammograms and scheduled for breast biopsy were randomized to consume a placebo or a glucoraphanin (GFN) supplement providing SFN (n = 27). Plasma and urinary SFN metabolites, peripheral blood mononuclear cell (PBMC) histone deacetylase (HDAC) activity, and tissue biomarkers (H3K18ac, H3K9ac, HDAC3, HDAC6, Ki-67, p21) were measured before and after the intervention in benign, ductal carcinoma in situ, or invasive ductal carcinoma breast tissues. Within the supplement group, Ki-67 (P = 0.003) and HDAC3 (P = 0.044) levels significantly decreased in benign tissue. Pre-to-postintervention changes in these biomarkers were not significantly different between treatment groups after multiple comparison adjustment. GFN supplementation was associated with a significant decrease in PBMC HDAC activity (P = 0.04). No significant associations were observed between SFN and examined tissue biomarkers when comparing treatment groups. This study provides evidence that GFN supplementation for a few weeks is safe but may not be sufficient for producing changes in breast tissue tumor biomarkers. Future studies employing larger sample sizes should evaluate alternative dosing and duration regimens to inform dietary SFN strategies in breast cancer chemoprevention.
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http://dx.doi.org/10.1158/1940-6207.CAPR-15-0119DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4670794PMC
December 2015

Long-term safety and efficacy of insulin degludec in the management of type 2 diabetes.

Diabetes Metab Syndr Obes 2015 1;8:483-93. Epub 2015 Oct 1.

Department of Endocrinology, Diabetology and Metabolic Diseases, Medical University Hospital of Brest La Cavale Blanche, Brest, France.

Insulin degludec (IDeg) is a novel antiglycemic agent belonging to the therapeutic class of ultra-long duration basal insulin analogs. Its half-life and duration of action are 25 hours and 42 hours, respectively. This pharmacodynamic profile leads to a strict dosing schedule, ie, IDeg is injected at the same time each day to ensure optimal biological action and consistent glycemic control. According to the literature, IDeg provides glycemic control and nocturnal hypoglycemia reduction comparable with other long-acting analogs in type 2 diabetes mellitus. The risk of severe hypoglycemic episodes seems also to be reduced when using IDeg therapy; however, long-term follow-up is warranted for monitoring of possible but relatively infrequent adverse events. IDeg is also available in combination with aspart insulin and with liraglutide. The above preparations have been approved by the European Medicines Agency and other national health authorities. In 2012, the US Food and Drug Administration asked for a complementary study on IDeg-associated cardiovascular risk. Future prospective evaluation of large cohorts of patients with type 2 diabetes mellitus treated with IDeg, with long-term follow-up, can provide further relevant information on the safety of IDeg therapy.
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http://dx.doi.org/10.2147/DMSO.S54953DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4598200PMC
October 2015
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