Publications by authors named "Raymond Oyen"

139 Publications

Renal Infarction Imaged With [18F]Prostate-Specific Membrane Antigen-1007 PET/CT.

Clin Nucl Med 2021 Oct 12. Epub 2021 Oct 12.

From the Departments of Nuclear Medicine Nephrology and Renal Transplantation, University Hospitals Leuven Department of Microbiology and Immunology, KU Leuven Department of Radiology, University Hospitals Leuven Nuclear Medicine and Molecular Imaging, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium.

Abstract: A 61-year-old post-renal transplant man developed pain in the region of the allograft 4 days after transplantation. Contrast-enhanced CT scan revealed multiple small perfusion defects in the renal graft cortex. Multifocal renal cortical infarction was suspected. A [99mTc]Tc-DMSA SPECT/CT showed several small regions with decreased uptake. In addition, an [18F]PSMA-1007 PET/CT confirmed these uptake defects and revealed additional defects. The renal cortical infarctions presumably originated from intraoperative emboli emerging from the arterial anastomosis. Treatment with acetylsalicylic acid 100 mg led to favorable evolution of the renal function biochemically. Follow-up DMSA scintigraphy 3 months later showed resolution of the renal cortical defects.
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http://dx.doi.org/10.1097/RLU.0000000000003924DOI Listing
October 2021

Getting Rid of Patient's Misconceptions About the Radiology Department Using Animated Video in the Waiting Room.

J Belg Soc Radiol 2021 29;105(1):41. Epub 2021 Jul 29.

UZLeuven, BE.

Objectives: Patients often confuse the role of the radiologist with that of the technician. The aim of this study is to explore patients' current perceptions about the radiology department and to evaluate how it's possible to get rid of misconceptions using informative animated video in the waiting room.

Materials And Methods: In this multi-centric study (UZ Leuven, ZNA Middelheim), 278 patients of all ages and education levels were surveyed in the radiology waiting room. 107 patients filled out the survey after watching an informative animated video (). The remaining patients did not watch the video.

Results: Half of the patients (86/171) in the non-video group believe the radiologist "performs the scanning", compared to 19% (20/107) in the video group (p < 0.001). Patients who think their own physician will interpret the images is 36% (61/171) in the non-video group and 10% (11/107) in the video group (p < 0.001). In the non-video group, 32% (55/171) believe the technician performs the exam compared to 59% (63/107) in the video group (p < 0.001). After the video, 67% (72/107) of patients have more respect for the work of the radiologist, 52% (56/107) experience less anxiety and 65% (70/107) think the video is of added value to their visit. All items showed a better impact in high-educational subgroups.

Conclusion: Animated informative videos help to increase patient knowledge about the radiology department. It moderates expectations, reduces anxiety, and ameliorates the overall experience. Although, the learning curve is steeper in highly educated patients, all educational levels benefit.
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http://dx.doi.org/10.5334/jbsr.2405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8323534PMC
July 2021

Prospective comparison of simultaneous [Ga]Ga-PSMA-11 PET/MR versus PET/CT in patients with biochemically recurrent prostate cancer.

Eur Radiol 2021 Aug 10. Epub 2021 Aug 10.

Nuclear Medicine, UZ Leuven, Herestraat, 49 3000, Leuven, Belgium.

Objectives: PSMA-PET has become the PET technique of choice to localise the site of biochemically recurrent prostate cancer (PCa). With hybrid PET/MRI, the advantages of MRI are added to molecular characteristic of PET. The aim of this study was to investigate the incremental value of PET/MR versus PET/CT in patients with biochemically recurrent PCa by head-to-head comparison.

Methods: Thirty-four patients with biochemically recurrent PCa were prospectively included. They underwent [Ga]Ga-PSMA-11 PET/CT, followed by simultaneous PET/MR. All PET (PET, PET), CT and MR images were evaluated for number of lesions and location. The number of lesions at specific sites was compared using Wilcoxon-sign-rank test. For PET, the maximum and mean standardised uptake values (SUVs) were calculated for each lesion compared using a two-sided paired t test.

Results: PET and PET scans were positive in 19 and 20 patients, detecting 73 and 79 lesions respectively. All lesions detected on PET were also detected on PET. CT and MRI only were positive in 14 and 17 patients, detecting 38 and 50 lesions, respectively, which was significantly lower than PET and PET respectively. Combined interpretation showed more lesions on PET/MR than on PET/CT (88 vs 81). No significant difference in detection of presence of local recurrence nor distant metastases was found. SUV and SUV values were significantly higher on PET than on PET in local recurrence and lymph node metastases.

Conclusions: [Ga]Ga-PSMA-11 PET/MR was able to detect biochemically recurrent PCa at least as accurately as PET/CT for local recurrence, lymph node metastasis and distant metastasis.

Key Points: • PSMA PET/MRI detects the location of biochemical recurrence at least as accurately as PET/CT. • Substitution of PET/CT by PET/MRI adds sensitivity in PSMA lesion detection also in the setting of distant recurrence due to both the MR and TOF PET components.
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http://dx.doi.org/10.1007/s00330-021-08140-0DOI Listing
August 2021

Ga-PSMA-11 PET, F-PSMA-1007 PET, and MRI for Gross Tumor Volume Delineation in Primary Prostate Cancer: Intermodality and Intertracer Variability.

Pract Radiat Oncol 2021 May-Jun;11(3):202-211

Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium; Department of Oncology, KU Leuven, Leuven, Belgium. Electronic address:

Purpose: To assess the intermodality and intertracer variability of gallium-68 (Ga)- or fluorine-18 (F)-labeled prostate-specific membrane antigen (PSMA) positron emission tomography (PET) and biparametric magnetic resonance imaging (bpMRI)-based gross tumor volume (GTV) delineation for focal boosting in primary prostate cancer.

Methods: Nineteen prospectively enrolled patients with prostate cancer underwent a PSMA PET/MRI scan, divided into a 1:1 ratio between Ga-PSMA-11 and F-PSMA-1007, before radical prostatectomy (IWT140193). Four delineation teams performed manual contouring of the GTV based on bpMRI and PSMA PET imaging, separately. Index lesion coverage (overlap%) and interobserver variability were assessed. Furthermore, the distribution of the voxelwise normalized standardized uptake values (SUV%) was determined for the majority-voted (>50%) GTV (GTV) and whole prostate gland to investigate intertracer variability. The median patientwise SUV% contrast ratio (SUV%-CR, calculated as median GTV SUV% / median prostate gland without GTV SUV%) was calculated according to the tracer used.

Results: A significant difference in overlap% favoring PSMA PET compared with bpMRI was found in the F subgroup (median, 63.0% vs 53.1%; P = .004) but was not present in the Ga subgroup (32.5% vs 50.6%; P = .100). Regarding interobserver variability, measured Sørensen-Dice coefficients (0.58 vs 0.72) and calculated mean distances to agreement (2.44 mm vs 1.22 mm) were statistically significantly lower and higher, respectively, for the F cohort compared with the Ga cohort. For the bpMRI-based delineations, the median Sørensen-Dice coefficient and mean distance to agreement were 0.63 and 1.76 mm, respectively. Median patientwise SUV%-CRs of 1.8 (interquartile range [IQR], 1.6-2.7) for F-PSMA and 3.3 (IQR, 2.7-5.9) for Ga-PSMA PET images were found.

Conclusions: Both MRI and PSMA PET provided consistent intraprostatic GTV lesion detection. However, the PSMA tracer seems to have a major influence on the contour characteristics, owing to an apparent difference in SUV% distribution in the prostate gland.
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http://dx.doi.org/10.1016/j.prro.2020.11.006DOI Listing
August 2021

Quantitative Whole-Body Diffusion-weighted MRI after One Treatment Cycle for Aggressive Non-Hodgkin Lymphoma Is an Independent Prognostic Factor of Outcome.

Radiol Imaging Cancer 2021 03 26;3(2):e200061. Epub 2021 Mar 26.

Departments of Radiology (K.N.D.P., F.D.K., R.O., V.V.), Nuclear Medicine (C.A.V.K., O.G., M.K.), Medical Oncology (O.B., P.W.), and Hematology (D.D., A.J., G.V.), University Hospitals Leuven, Belgium; and Department of Radiology, University Hospital of Brescia, Brescia, Italy (G.M.A.).

Purpose: To evaluate the prognostic utility of apparent diffusion coefficient (ADC) changes at whole-body diffusion-weighted (WB-DW) MRI after one treatment cycle for aggressive non-Hodgkin lymphoma (NHL) compared with response assessment at interim and end-of-treatment fluorine 18 (F) fluorodeoxyglucose (FDG) PET/CT.

Materials And Methods: This was a secondary analysis of a prospective study (ClinicalTrials.gov identifier: NCT01231269) in which participants with aggressive NHL were recruited between March 2011 and April 2015 and underwent WB-DW MRI before and after one cycle of immunochemotherapy. Volunteers were recruited for test-retest WB-DW MRI (ClinicalTrials.gov identifier: NCT01231282) to assess ADC measurement repeatability. Response assessment was based on ADC change after one treatment cycle at WB-DW MRI and Deauville criteria at F-FDG PET/CT. To evaluate prognostic factors of disease-free survival (DFS), Kaplan-Meier survival analysis and univariable and multivariable Cox regression were performed; intraclass correlation coefficient (ICC) and mean difference with limits of agreement were calculated to determine inter- and intraobserver repeatability of ADC measurements.

Results: Forty-five patients (mean age, 58 years ± 17 [standard deviation]; 31 men) and nine volunteers (mean age, 22 years ± 3; seven men) were enrolled. Median DFS was 48 months (range, 2-48 months). Outcome prediction accuracy was 86.7% (39 of 45), 71.4% (30 of 42), and 73.8% (31 of 42) for WB-DW MRI and interim and end-of-treatment F-FDG PET/CT, respectively. WB-DW MRI (hazard ratio [HR], 17.8; < .001) and interim (HR, 5; = .008) and end-of-treatment (HR, 4.3; = .017) F-FDG PET/CT were prognostic of DFS. After multivariable analysis, WB-DW MRI remained an independent predictor of outcome (HR, 26.8; = .002). Intra- and interobserver agreement for ADC measurements were excellent (ICC = 0.85-0.99).

Conclusion: Quantitative WB-DW MRI after only one cycle of immunochemotherapy predicts DFS in aggressive NHL and is noninferior to routinely performed interim and end-of-treatment F-FDG PET/CT. MR-Diffusion Weighted Imaging, Lymphoma, Oncology, Tumor Response, Whole-Body Imaging© RSNA, 2021.
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http://dx.doi.org/10.1148/rycan.2021200061DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8011451PMC
March 2021

BSR Annual Meeting 2020.

Authors:
Raymond Oyen

J Belg Soc Radiol 2020 Nov 13;104(1):65. Epub 2020 Nov 13.

University Hospitals Leuven, BE.

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http://dx.doi.org/10.5334/jbsr.2327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7664299PMC
November 2020

BSR 2020 Annual Meeting: Program.

J Belg Soc Radiol 2020 Nov 13;104(1):63. Epub 2020 Nov 13.

University Hospitals Gasthuisberg, Leuven, BE.

Different times call for different measures. The COVID-19 pandemic has forced us to search for alternative methods to provide an annual meeting which is equally interesting and has quality. For the Belgian Society of Radiology (BSR) 2020 Annual Meeting, the sections on Abdominal Imaging, Thoracic Imaging and the Young Radiologist Section (YRS) joined forces to organize a meeting which is quite different from the ones we have organised in the past. We have chosen to create a compact - approximately 5 hour - and entirely virtual meeting with the possibility of live interaction with the speakers during the question and answer sessions. The meeting kicks off with a message from the BSR president about radiology in 2020, followed by three abdominal talks. The second session combines an abdominal talk with COVID-related talks. We have chosen to include not only thoracic findings in COVID-19, but to take it further and discuss neurological patterns, long-term clinical findings and the progress in artificial intelligence in COVID-19. Lastly, the annual meeting closes off with a short movie about the (re)discovery of Röntgens X-ray, presented to us by the Belgian Museum for Radiology, Military Hospital, Brussels.
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http://dx.doi.org/10.5334/jbsr.2311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7664300PMC
November 2020

Optimal Ga-PSMA and F-PSMA PET window levelling for gross tumour volume delineation in primary prostate cancer.

Eur J Nucl Med Mol Imaging 2021 04 6;48(4):1211-1218. Epub 2020 Oct 6.

Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.

Purpose: This study proposes optimal tracer-specific threshold-based window levels for PSMA PET-based intraprostatic gross tumour volume (GTV) contouring to reduce interobserver delineation variability.

Methods: Nine Ga-PSMA-11 and nine F-PSMA-1007 PET scans including GTV delineations of four expert teams (GTV) and a majority-voted GTV (GTV) were assessed with respect to a registered histopathological GTV (GTV) as the gold standard reference. The standard uptake values (SUVs) per voxel were converted to a percentage (SUV%) relative to the SUV. The statistically optimised SUV% threshold (SOST) was defined as those that maximises accuracy for threshold-based contouring. A leave-one-out cross-validation receiver operating characteristic (ROC) curve analysis was performed to determine the SOST for each tracer. The SOST analysis was performed twice, first using the GTV contour as training structure (GTV) and second using the GTV contour as training structure (GTV) to correct for any limited misregistration. The accuracy of both GTV and GTV was calculated relative to GTV in the 'leave-one-out' patient of each fold and compared with the accuracy of GTV.

Results: ROC curve analysis for Ga-PSMA-11 PET revealed a median threshold of 25 SUV% (range, 22-27 SUV%) and 41 SUV% (40-43 SUV%) for GTV and GTV, respectively. For F-PSMA-1007 PET, a median threshold of 42 SUV% (39-45 SUV%) for GTV and 44 SUV% (42-45 SUV%) for GTV was found. A significant pairwise difference was observed when comparing the accuracy of the GTV contours with the median accuracy of the GTV contours (median, - 2.5%; IQR, - 26.5-0.2%; p = 0.020), whereas no significant pairwise difference was found for the GTV contours (median, - 0.3%; IQR, - 4.4-0.6%; p = 0.199).

Conclusions: Threshold-based contouring using GTV-trained SOSTs achieves an accuracy comparable with manual contours in delineating GTV. The median SOSTs of 41 SUV% for Ga-PSMA-11 PET and 44 SUV% for F-PSMA-1007 PET form a base for tracer-specific window levelling.

Trial Registration: Clinicaltrials.gov ; NCT03327675; 31-10-2017.
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http://dx.doi.org/10.1007/s00259-020-05059-4DOI Listing
April 2021

Incidence and prognosis of liver metastasis at diagnosis: a pan-cancer population-based study.

Am J Cancer Res 2020 1;10(5):1477-1517. Epub 2020 May 1.

KU Leuven, Campus Gasthuisberg, Faculty of Medicine Leuven 3000, Belgium.

Metastasis is a major cause of cancer-related death and liver metastasis (LM) is a distinct type for its relatively good prognosis after timely treatment for selected patients. However, a generalizable estimation of incidence and prognosis of LM is lacking. Cancer patients with known LM status in the Surveillance, Epidemiology and End Results database were enrolled in the present study. The incidence and prognosis of LM were calculated by primary cancer type and clinicopathological factors. Among 1,630,725 cases, 105,329 (6.46%) cases present LM at diagnosis, with a median survival of 4 months. LM presents at diagnosis in 39.96% of pancreatic cancer, 16.00% of colorectal cancer (CRC) and 12.68% of lung cancer. Of all LM cases, 25.58% originated from lung cancer, with 24.76% from CRC and 17.55% from pancreatic cancer. LM originated from small intestine cancer shows the best prognosis (median survival: 30 months), followed by testis cancer (25 months) and breast cancer (15 months). Subgroup analyses demonstrated disparities in incidence and prognosis of LM, with higher incidence and poorer prognosis in the older population, African American, male, and patients with inferior socioeconomic status. The current study provides a generalizable data resource for the epidemiology of LM, which may help tailor screening protocol, design clinical trials and estimate disease burden.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7269791PMC
May 2020

ECCO Essential Requirements for Quality Cancer Care: Prostate cancer.

Crit Rev Oncol Hematol 2020 Apr 7;148:102861. Epub 2020 Jan 7.

European Cancer Organisation (ECCO).

Background: ECCO Essential Requirements for Quality Cancer Care (ERQCC) are written by experts representing all disciplines involved in cancer care in Europe. They give oncology teams, patients, policymakers and managers an overview of essential care throughout the patient journey.

Prostate Cancer: Prostate cancer is the second most common male cancer and has a wide variation in outcomes in Europe. It has complex diagnosis and treatment challenges, and is a major healthcare burden. Care must only be a carried out in prostate/urology cancer units or centres that have a core multidisciplinary team (MDT) and an extended team of health professionals. Such units are far from universal in European countries. To meet European aspirations for comprehensive cancer control, healthcare organisations must consider the requirements in this paper, paying particular attention to multidisciplinarity and patient-centred pathways from diagnosis, to treatment, to survivorship.
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http://dx.doi.org/10.1016/j.critrevonc.2019.102861DOI Listing
April 2020

Safety and efficacy of embolotherapy for severe hemorrhage after partial nephrectomy.

Acta Radiol 2020 Dec 26;61(12):1701-1707. Epub 2020 Feb 26.

Department of Radiology, University Hospitals Leuven, Leuven, Belgium.

Background: Partial nephrectomy may be complicated by postoperative hemorrhage, which may be treated by transcatheter embolization.

Purpose: To assess the safety and efficacy of embolotherapy for hemorrhagic complications of partial nephrectomy and to analyze the potential correlation between multiple bleeding sites on angiography and surgical complexity.

Material And Methods: A cohort of 25 patients presenting with severe, postoperative bleeding after partial nephrectomy and treated with catheter-directed superselective embolization was included. Patients' demographics, radiological investigations before the embolization, and clinical outcome after embolization were analyzed. Mann-Whitney U test was used to analyze the potential difference in the RENAL score between patients with one or more bleeding sites in the resection area.

Results: Selective renal angiography revealed multiple bleeding sites at the resection bed in 8 (32%) patients with amorphous contrast extravasation in 10 (40%) patients. Embolization with use of a microcatheter and microcoils was effective to stop the bleeding in all but one patient, the latter requiring a second embolization two days later. Transient decrease in renal function was noted in 3/25 (12%) patients with full recovery in two of the three. Patients with multiple bleeding sites did not show significantly different RENAL scores compared to patients with a single bleeding site ( = 0.148).

Conclusion: Embolotherapy for postoperative partial nephrectomy-related bleeding is safe and effective with a low rate of recurrent bleeding. The number of bleeding sites at the resection area did not correlate to the RENAL score.
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http://dx.doi.org/10.1177/0284185120907253DOI Listing
December 2020

Predicting Clinical Efficacy of Vascular Disrupting Agents in Rodent Models of Primary and Secondary Liver Cancers: An Overview with Imaging-Histopathology Correlation.

Diagnostics (Basel) 2020 Jan 31;10(2). Epub 2020 Jan 31.

Shanghai Key Laboratory of Molecular Imaging, Shanghai University of Medicine and Health Sciences, Shanghai 201318, China.

Vascular disrupting agents (VDAs) have entered clinical trials for over 15 years. As the leading VDA, combretastatin A4 phosphate (CA4P) has been evaluated in combination with chemotherapy and molecular targeting agents among patients with ovarian cancer, lung cancer and thyroid cancer, but still remains rarely explored in human liver cancers. To overcome tumor residues and regrowth after CA4P monotherapy, a novel dual targeting pan-anticancer theragnostic strategy, i.e., OncoCiDia, has been developed and shown promise previously in secondary liver tumor models. Animal model of primary liver cancer is time consuming to induce, but of value for more closely mimicking human liver cancers in terms of tumor angiogenesis, histopathological heterogeneity, cellular differentiation, tumor components, cancer progression and therapeutic response. Being increasingly adopted in VDA researches, multiparametric magnetic resonance imaging (MRI) provides imaging biomarkers to reflect in vivo tumor responses to drugs. In this article as a chapter of a doctoral thesis, we overview the construction and clinical relevance of primary and secondary liver cancer models in rodents. Target selection for CA4P therapy assisted by enhanced MRI using hepatobiliary contrast agents (CAs), and therapeutic efficacy evaluated by using MRI with a non-specific contrast agent, dynamic contrast enhanced (DCE) imaging, diffusion weighted imaging (DWI) are also described. We then summarize diverse responses among primary hepatocellular carcinomas (HCCs), secondary liver and pancreatic tumors to CA4P, which appeared to be related to tumor size, vascularity, and cellular differentiation. In general, imaging-histopathology correlation studies allow to conclude that CA4P tends to be more effective in secondary liver tumors and in more differentiated HCCs, but less effective in less differentiated HCCs and implanted pancreatic tumor. Notably, cirrhotic liver may be responsive to CA4P as well. All these could be instructive for future clinical trials of VDAs.
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http://dx.doi.org/10.3390/diagnostics10020078DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7168934PMC
January 2020

Initial Experience With the Microvascular Plug in Selective Renal Artery Embolization.

Vasc Endovascular Surg 2020 Apr 13;54(3):240-246. Epub 2020 Jan 13.

Department of Radiology, University Hospitals Leuven, Leuven, Belgium.

Purpose: To evaluate the safety and efficacy of the microvascular plug (MVP) for selective renal artery embolization.

Methods: Retrospective review was performed on a cohort of 6 patients undergoing renal artery embolization using the MVP between July 2015 and August 2018. Patients' demographics, indication for embolization, technical details of the embolization procedure, and clinical events were gathered from the patients' electronic medical records.

Results: The patients underwent selective renal artery embolization with a MVP for iatrogenic vascular injuries (n = 3), traumatic vascular injuries (n = 2), and for elective embolization of an angiomyolipoma (n = 1), in native kidneys (n = 4) or in renal allografts (n = 2). Immediate occlusion of the feeding artery was achieved with 1 MVP device in 4 patients. In 1 patient, a second MVP was needed, and in another patient, additional 0.018-inch microcoils were used to completely occlude the injured artery. Technical success was achieved in all patients. The volume of the resulting renal infarction was estimated less than 5% of the renal volume. No other procedure-related complications occurred.

Conclusion: The MVP is a safe and effective device allowing superselective renal artery embolization. Therefore, we recommend the MVP as a valuable embolic in superselective renal artery embolization. Additionally, a single device is sufficient in most cases, potentially reducing the cost, duration, and radiation exposure of the procedure.
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http://dx.doi.org/10.1177/1538574419897500DOI Listing
April 2020

Predicting Therapeutic Efficacy of Vascular Disrupting Agent CA4P in Rats with Liver Tumors by Hepatobiliary Contrast Agent Mn-DPDP-Enhanced MRI.

Transl Oncol 2020 Jan 3;13(1):92-101. Epub 2019 Dec 3.

Shanghai Key Laboratory of Molecular Imaging, Shanghai University of Medicine and Health Sciences, Shanghai 201318, China; Biomedical Group, Campus Gasthuisberg, KU Leuven, Leuven 3000, Belgium. Electronic address:

To evaluate hepatobiliary-specific contrast agent (CA) mangafodipir trisodium (Mn-DPDP)-enhanced magnetic resonance imaging (MRI) for predicting the therapeutic efficacy of the vascular disrupting agent combretastatin A4 phosphate (CA4P) in rats with primary and secondary liver tumors, 36 primary hepatocellular carcinomas (HCCs) were raised by diethylnitrosamine gavage in 16 male rats, in 6 of which one rhabdomyosarcomas (R1) was intrahepatically implanted as secondary liver tumors. On a 3.0T MR scanner with a wrist coil, tumors were monitored weekly by T2-/T1-weighted images (T2WI/T1WI) and characterized by Mn-DPDP-enhanced MRI. CA4P-induced intratumoral necrosis was depicted by nonspecific gadoterate meglumine (Gd-DOTA)-enhanced MRI before and 12 h after therapy. Changes of tumor-to-liver contrast (ΔT/L) on Mn-DPDP-enhanced images were analyzed. In vivo MRI findings were verified by postmortem microangiography and histopathology. Rat models of primary HCCs in a full spectrum of differentiation and secondary R1 liver tumors were successfully generated. Mn-DPDP-enhanced ΔT/L was negatively correlated with HCC differentiation grade (P < 0.01). After treatment with CA4P, more extensive tumoral necrosis was found in highly differentiated HCCs than that in moderately and poorly differentiated ones (P < 0.01); nearly complete necrosis was induced in secondary liver tumors. Mn-DPDP-enhanced MRI may help in imaging diagnosis of primary and secondary liver malignancies of different cellular differentiations and further in predicting CA4P therapeutic efficacy in primary HCCs and intrahepatic metastases.
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http://dx.doi.org/10.1016/j.tranon.2019.09.010DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6909075PMC
January 2020

Summary BSR Annual Meeting 2019.

Authors:
Raymond Oyen

J Belg Soc Radiol 2019 Nov 16;103(1):77. Epub 2019 Nov 16.

University Hospitals Leuven, BE.

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http://dx.doi.org/10.5334/jbsr.1959DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6873893PMC
November 2019

Anatomical mapping of lymph nodes in patients receiving salvage lymphadenectomy based on a positive 11C-choline positron emission tomography/computed tomography scan.

Cent European J Urol 2019 5;72(3):232-239. Epub 2019 Sep 5.

Nuclear Medicine, UZ Leuven, Leuven, Belgium.

Introduction: This paper aims to assess the diagnostic accuracy of an 11C-choline positron emission tomography/computed tomography (PET/CT) scan in the detection of lymph node (LN) metastases in patients with biochemical recurrence after radically treated prostate cancer (PCa), as compared to histology. The secondary goal is to depict spreading patterns of metastatic LNs in recurrent PCa.

Material And Methods: A single center retrospective study comprising of 30 patients who underwent retroperitoneal and/or pelvic salvage lymph node dissection (LND) due to 11C-choline PET/CT-positive nodal recurrences after radical treatment (median Prostate Specific Antigen (PSA) 1.5 ng/ml, range 0.2-11.4). Positive nodes on the preoperative PET/CT scans were mapped and compared to post-operative pathology results.LNs were marked as true positive, false positive, true negative and false negative and a patient- and a region-based analysis was performed. Sensitivity, specificity and positive/negative predictive value (PPV/NPV) were calculated.

Results: Sixty positive LNs were detected on PET/CT with a median number of two positive nodes per patient (range 1-6). In 29 patients, a super-extended pelvic LND (PLND) was performed combined with a retroperitoneal LND (RPLND) in 13 of those cases. One patient underwent an inguinal LND. One hundred thirty-seven of 644 resected LNs contained metastases. The 11C-choline PET/CT scan correctly predicted 31 positive nodes (55%) while 25 nodes were falsely positive (45%). One hundred and six histologically proven metastatic nodes were not detected on the 11C-choline PET/CT scan (77%). Sensitivity, specificity, PPV and NPV of the 11C-choline PET/CT were 23%, 95%, 55% and 82%, respectively.

Conclusions: 11C-choline PET/CT has a relatively low detection rate and a moderate PPV for metastatic LNs in patients with biochemical recurrence after radically treated PCa.
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http://dx.doi.org/10.5173/ceju.2019.1910DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6830482PMC
September 2019

Development and External Validation of a Multiparametric Magnetic Resonance Imaging and International Society of Urological Pathology Based Add-On Prediction Tool to Identify Prostate Cancer Candidates for Pelvic Lymph Node Dissection.

J Urol 2020 Apr 13;203(4):713-718. Epub 2019 Nov 13.

Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium.

Purpose: We sought to expand current prediction tools for lymph node invasion in patients with prostate cancer using current state-of-the-art available tumor information, including multiparametric magnetic resonance imaging based tumor stage and detailed biopsy information.

Materials And Methods: We selected patients with prostate cancer for study who had available registered information on ISUP (International Society of Urological Pathology) based biopsy grading and multiparametric magnetic resonance imaging, and who had undergone radical prostatectomy with extended pelvic lymph node dissection. We developed a lymph node invasion prediction tool in 420 patients and externally validated it in 187. A concordance index was estimated to quantify the discriminative performance of the model.

Results: In the development cohort a median of 21 lymph nodes were removed per patient and 71 patients (16.9%) were diagnosed with lymph node invasion. Statistically significant predictors of lymph node invasion were the initial prostate specific antigen value, multiparametric magnetic resonance imaging based T stage, maximum tumor length in 1 core in mm and ISUP grade group corresponding to the maximum tumor involvement in 1 core. The predictive accuracy of this lymph node invasion prediction tool was 79.7% after fivefold internal cross validation and 72.5% after external validation.

Conclusions: We report a contemporary, externally validated prediction tool for lymph node invasion in patients with prostate cancer. This prediction tool is a response to the paradigm shift from systematic to targeted biopsies by incorporating additional core specific biopsy information instead of the percent of positive cores. This new tool will also overcome stage migration, which is a potential risk when multiparametric magnetic resonance imaging information is used in digital rectal examination based nomograms.
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http://dx.doi.org/10.1097/JU.0000000000000652DOI Listing
April 2020

Impact of Magnetic Resonance Imaging on Prostate Cancer Staging and European Association of Urology Risk Classification.

Urology 2019 Aug 30;130:113-119. Epub 2019 Apr 30.

Department of Radiation Oncology, University Hospitals Leuven, Leuven, Belgium; Department of Oncology, KU Leuven, Leuven, Belgium.

Objective: To investigate the impact of magnetic resonance imaging (MRI) information on clinical staging, risk stratification, and treatment recommendations for prostate cancer (PCa) according to the European Association of Urology (EAU) guidelines.

Methods: We performed a single-center analysis of 180 men with PCa, undergoing clinical staging by digital rectal examination (DRE) as well as MRI before their robot-assisted radical prostatectomy. Patients were stratified according to the EAU guidelines into 4 well-defined risk categories, based on their clinical T-stage assessed by either DRE or MRI. Descriptive statistics of categorical variables are shown as frequencies and proportions. Differences between both scenarios (DRE- vs MRI-staged) were analyzed using a paired-samples sign test.

Results: Use of MRI information instead of DRE information leads to significant upstaging of clinical T-stage (33%) and EAU risk grouping (31%). When comparing these results with the pathologic T-stage, MRI showed a higher sensitivity than DRE to detect nonorgan-confined PCa (59% vs 41%; P <.01). In contrast, the specificity of MRI was lower than DRE (69% vs 95%; P <.01). Incorporation of MRI-based instead of DRE-based staging in the treatment decision process would alter the surgical treatment strategy in 49/180 patients (27%).

Conclusion: The incorporation of MRI information substantially affects the treatment choice in PCa patients as compared to using the current available EAU guidelines based on DRE information. More specifically, treatment intensification would be recommended in 1 out of 4 patients.
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http://dx.doi.org/10.1016/j.urology.2019.04.023DOI Listing
August 2019

Summary of the BSR Annual Meeting 2017.

Authors:
Raymond Oyen

J Belg Soc Radiol 2017 Nov 18;101(Suppl 1):16. Epub 2017 Nov 18.

UZ Leuven, BE.

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http://dx.doi.org/10.5334/jbr-btr.1442DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6253055PMC
November 2017

Summary BSR Annual Meeting 2018.

Authors:
Raymond Oyen

J Belg Soc Radiol 2018 Nov 17;102(Suppl 1). Epub 2018 Nov 17.

UZ Leuven, BE.

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http://dx.doi.org/10.5334/jbsr.1669DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6266724PMC
November 2018

Monitoring reperfused myocardial infarction with delayed left ventricular systolic dysfunction in rabbits by longitudinal imaging.

Quant Imaging Med Surg 2018 Sep;8(8):754-769

Radiology, Department of Imaging and Pathology, KU Leuven, Leuven, Belgium.

Background: An experimental imaging platform for longitudinal monitoring and evaluation of cardiac morphology-function changes has been long desired. We sought to establish such a platform by using a rabbit model of reperfused myocardial infarction (MI) that develops chronic left ventricle systolic dysfunction (LVSD) within 7 weeks.

Methods: Fifty-five New Zeeland white (NZW) rabbits received sham-operated or 60-min left circumflex coronary artery (LCx) ligation followed by reperfusion. Cardiac magnetic resonance imaging (cMRI), transthoracic echocardiography (echo), and blood samples were collected at baseline, in acute (48 hours or 1 week) and chronic (7 weeks) stage subsequent to MI for assessment of infarct size, cardiac morphology, LV function, and myocardial enzymes. Seven weeks post MI, animals were sacrificed and heart tissues were processed for histopathological staining.

Results: The success rate of surgical operation was 87.27%. The animal mortality rates were 12.7% and 3.6% both in acute and chronic stage separately. Serum levels of the myocardial enzyme cardiac Troponin T (cTnT) were significantly increased in MI rabbits as compared with sham animals after 4 hours of operation (P<0.05). According to cardiac morphology and function changes, 4 groups could be distinguished: sham rabbits (n=12), and MI rabbits with no (MI_NO_LVSD; n=10), moderate (MI_M_LVSD; n=9) and severe (MI_S_LVSD; n=15) LVSD. No significant differences in cardiac function or wall thickening between sham and MI_NO_LVSD rabbits were observed at both stages using both cMRI and echo methods. cMRI data showed that MI_M_LVSD rabbits exhibited a reduction of ejection fraction (EF) and an increase in end-systolic volume (ESV) at the acute phase, while at the chronic stage these parameters did not change further. Moreover, in MI_S_LVSD animals, these observations were more striking at the acute stage followed by a further decline in EF and increase in ESV at the chronic stage. Lateral wall thickening determined by cMRI was significantly decreased in MI_M_LVSD versus MI_NO_LVSD animals at both stages (P<0.05). As for MI_S_LVSD versus MI_M_LVSD rabbits, the thickening of anterior, inferior and lateral walls was significantly more decreased at both stages (P<0.05). Echo confirmed the findings of cMRI. Furthermore, these outcomes including those from vivid cine cMRI could be supported by exactly matched histomorphological evidences.

Conclusions: Our findings indicate that chronic LVSD developed over time after surgery-induced MI in rabbits can be longitudinally evaluated using non-invasive imaging techniques and confirmed by the entire-heart-slice histomorphology. This experimental LVSD platform in rabbits may interest researchers in the field of experimental cardiology and help strengthen drug development and translational research for the management of cardiovascular diseases.
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http://dx.doi.org/10.21037/qims.2018.09.05DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6177364PMC
September 2018

Sonographically indeterminate scrotal masses: how MRI helps in characterization.

Diagn Interv Radiol 2018 Jul;24(4):225-236

Royal Sussex County Hospital Brighton and Brighton and Sussex Medical School, Brighton, Sussex, UK.

Magnetic resonance imaging (MRI) of the scrotum represents a useful supplemental imaging technique in the characterization of scrotal masses, particularly recommended in cases of nondiagnostic ultrasonographic findings. An accurate characterization of the benign nature of scrotal masses, including both intratesticular and paratesticular ones may improve patient management and decrease the number of unnecessary radical surgical procedures. Alternative treatment strategies, including follow-up, lesion biopsy, tumor enucleation, or organ sparing surgery may be recommended. The aim of this pictorial review is to present how MRI helps in the characterization of sonographically indeterminate scrotal masses and to emphasize the key MRI features of benign scrotal masses.
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http://dx.doi.org/10.5152/dir.2018.17400DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6045519PMC
July 2018

Renal Angiomyolipoma: The Good, the Bad, and the Ugly.

J Belg Soc Radiol 2018 Apr 20;102(1):41. Epub 2018 Apr 20.

University Hospitals Leuven, BE.

Angiomyolipomas (AMLs) are the most common benign renal tumours. Most of these neoplasms are found incidentally on imaging. However, symptomatic presentation does exist. Renal AMLs are typically composed of smooth muscle, blood vessels, and adipose tissue. Because of the abundant fat tissue, they give a characteristic appearance on imaging and are therefore easily diagnosed. However, sometimes they contain too little fat to be detected. This increases the difficulty in differentiating them from renal cell carcinoma (RCC). Management of AML is based on clinical presentation and should be individualized for every patient. Treatment modalities range from active surveillance to more invasive approaches.
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http://dx.doi.org/10.5334/jbsr.1536DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6032655PMC
April 2018

Intra-individual comparison of therapeutic responses to vascular disrupting agent CA4P between rodent primary and secondary liver cancers.

World J Gastroenterol 2018 Jul;24(25):2710-2721

Biomedical Group, Campus Gasthuisberg, KU Leuven, Leuven 3000, Belgium.

Aim: To compare therapeutic responses of a vascular-disrupting-agent, combretastatin-A4-phosphate (CA4P), among hepatocellular carcinomas (HCCs) and implanted rhabdomyosarcoma (R1) in the same rats by magnetic-resonance-imaging (MRI), microangiography and histopathology.

Methods: Thirty-six HCCs were created by diethylnitrosamine gavage in 14 rats that were also intrahepatically implanted with one R1 per rat as monitored by T2-/T1-weighted images (T2WI/T1WI) on a 3.0T clinical MRI-scanner. Vascular response and tumoral necrosis were detected by dynamic contrast-enhanced (DCE-) and CE-MRI before, 1 h after and 12 h after CA4P iv at 10 mg/kg (treatment group = 7) or phosphate-buffered saline at 1.0 mL/kg (control group = 7). Tumor blood supply was calculated by a semiquantitative DCE parameter of area under the time signal intensity curve (AUC30). MRI findings were verified by postmortem techniques.

Results: On CE-T1WIs, unlike the negative response in all tumors of control animals, in treatment group CA4P caused rapid extensive vascular shutdown in all R1-tumors, but mildly or spottily in HCCs at 1 h. Consequently, tumor necrosis occurred massively in R1-tumors but patchily in HCCs at 12 h. AUC30 revealed vascular closure (66%) in R1-tumors at 1 h ( < 0.05), followed by further perfusion decrease at 12 h ( < 0.01), while less significant vascular clogging occurred in HCCs. Histomorphologically, CA4P induced more extensive necrosis in R1-tumors (92.6%) than in HCCs (50.2%) ( < 0.01); tumor vascularity heterogeneously scored +~+++ in HCCs but homogeneously scored ++ in R1-tumors.

Conclusion: This study suggests superior performance of CA4P in metastatic over primary liver cancers, which could guide future clinical applications of vascular-disrupting-agents.​.
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http://dx.doi.org/10.3748/wjg.v24.i25.2710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6034151PMC
July 2018

Prospective evaluation of hypogonadism in male metastatic renal cell carcinoma patients treated with targeted therapies.

Acta Clin Belg 2019 Jun 18;74(3):169-179. Epub 2018 May 18.

a Department of General Medical Oncology , University Hospitals Leuven, Leuven Cancer Institute, KULeuven , Leuven , Belgium.

Objectives: To study the prevalence of hypogonadism in male patients with metastatic renal cell carcinoma (mRCC) starting with targeted therapies and the impact of the vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) sunitinib and pazopanib on the luteinizing hormone (LH)/testosterone (TT)-axis.

Methods: Male mRCC patients starting with targeted therapies were prospectively included in this study. TT- and LH-levels were sampled at start as well as during systemic therapy. Endpoints of the study were gonadal status (TT- and LH-levels) at start of targeted therapy and TT- and LH-evolution during targeted therapy.

Results: Sixty-three patients were included in this study. At start of targeted therapy, 30% of patients were eugonadal and 48% had secondary hypogonadism. Decreased TT- and increased LH-levels were associated with inflammatory state and poor prognosis. During sunitinib therapy, TT-levels decreased with 32% (p = 0.004) and LH-levels with 14% (p = 0.03). TT-levels were 13% lower (p = 0.007) and LH-levels 15% lower (p = 0.004) on day 28 compared to day 1. In four patients, a dramatic TT decrease was observed shortly after starting sunitinib. In patients treated with pazopanib, no impact on TT- or LH-levels was observed.

Conclusion: Hypogonadism is a frequent finding in male mRCC-patients at start of targeted therapies. In contrast to pazopanib, during sunitinib therapy, TT- and LH-levels tend to decrease, leading to an increased incidence of secondary hypogonadism.
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http://dx.doi.org/10.1080/17843286.2018.1476115DOI Listing
June 2019

Contouring of prostate tumors on multiparametric MRI: Evaluation of clinical delineations in a multicenter radiotherapy trial.

Radiother Oncol 2018 08 3;128(2):321-326. Epub 2018 May 3.

Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address:

Purpose: To date no guidelines are available for contouring prostate cancer inside the gland, as visible on multiparametric (mp-) MRI. We assessed inter-institutional differences in interpretation of mp-MRI in the multicenter phase III FLAME trial.

Methods: We analyzed clinical delineations on mp-MRI and clinical characteristics from 260 patients across three institutes. We performed a logistic regression analysis to examine each institute's weighting of T2w, ADC and K intensity maps in the delineation of the cancer. As reviewing of all delineations by an expert panel is not feasible, we made a selection based on discrepancies between a published tumor probability (TP) model and each institute's clinical delineations using Areas Under the ROC Curve (AUC) analysis.

Results: Regression coefficients for the three institutes were -0.07, -0.27 and -0.11 for T2w, -1.96, -0.53 and -0.65 for ADC and 0.15, 0.20 and 0.62 for K, with significant differences between institutes for ADC and K. AUC analysis showed median AUC values of 0.92, 0.80 and 0.79. Five patients with lowest AUC values were reviewed by a uroradiologist.

Conclusion: Regression coefficients revealed considerably different interpretations of mp-MRI in tumor contouring between institutes and demonstrated the need for contouring guidelines. Based on AUC values outlying delineations could efficiently be identified for review.
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http://dx.doi.org/10.1016/j.radonc.2018.04.015DOI Listing
August 2018

The first study on therapeutic efficacies of a vascular disrupting agent CA4P among primary hepatocellular carcinomas with a full spectrum of differentiation and vascularity: Correlation of MRI-microangiography-histopathology in rats.

Int J Cancer 2018 10 3;143(7):1817-1828. Epub 2018 Jul 3.

Biomedical Group, Campus Gasthuisberg, KU Leuven, Leuven, Belgium.

To better inform the next clinical trials of vascular disrupting agent combretastatin-A4-phosphate (CA4P) in patients with hepatic malignancies, this preclinical study aimed at evaluating CA4P therapeutic efficacy in rats with primary hepatocellular carcinomas (HCCs) of a full spectrum of differentiation and vascularity by magnetic resonance imaging (MRI), microangiography and histopathology. Ninety-six HCCs were raised in 25 rats by diethylnitrosamine gavage. Tumor growth was monitored by T2-/T1-weighted-MRI (T2WI, T1WI) using a 3.0 T scanner. Early vascular response and later intratumoral necrosis were detected by dynamic-contrast-enhanced (DCE) MRI and diffusion-weighted-imaging (DWI) before, 1 and 12 hr after CA4P iv-administration. In vivo MRI-findings were validated by postmortem-techniques. Multi-parametric MRI revealed rapid CA4P-induced tumor vascular shutdown within 1 hr, followed by variable intratumoral necrosis at 12 hr. Tumor volumes decreased by 10% at 1 hr (p < 0.05), but resumed at 12 hr. Correlations of semi-quantitative DCE parameter initial-area-under-the-gadolinium-curve (IAUGC30) with histopathology proved partial vascular closure and compensational reopening (p < 0.05). The higher grades of vascularity prevented those residual tumor tissues from CA4P-caused ischemic necrosis. By histopathology using a 4-scale cellular-differentiation criteria and a 4-grade tumor-vascularity classification, percentage of CA4P-induced necrosis negatively correlated with HCC differentiation (r = -0.404, p < 0.001) and tumor vascularity (r = -0.370, p < 0.001). Ordinal-logistic-regression helped to predict early tumor responses to CA4P in terms of tumoral differentiation and vascularity. Our study demonstrated that CA4P could induce vascular shutdown in primary HCCs within 1 hr, resulting in various degrees of tumor necrosis at 12 hr. MRI as a real-time imaging biomarker may help to define tumor vascularity and differentiation and further to predict CA4P therapeutic outcomes.
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http://dx.doi.org/10.1002/ijc.31567DOI Listing
October 2018

Improving lymph node characterization in staging malignant lymphoma using first-order ADC texture analysis from whole-body diffusion-weighted MRI.

J Magn Reson Imaging 2018 10 14;48(4):897-906. Epub 2018 Apr 14.

Deparment of Radiology, University Hospitals Leuven, Belgium.

Background: Correct staging and treatment initiation in malignant lymphoma depends on accurate lymph node characterization. However, nodal assessment based on conventional and diffusion-weighted (DWI) MRI remains challenging, particularly in smaller nodes.

Purpose: To evaluate first-order apparent diffusion coefficient (ADC) texture parameters compared to mean ADC for lymph node characterization in non-Hodgkin lymphoma (NHL) using whole-body DWI (WB-DWI).

Study Type: Retrospective.

Population: Twenty-eight patients with NHL.

Field Strength/sequence: 3T whole-body DWI using two b-values (0-1000 s/mm ).

Assessment: Regions of interest were drawn on the three most hyperintense lymph nodes on b1000-images, irrespective of size, in all nodal body regions. Diagnostic performance of mean ADC (ADC ) was compared with first-order ADC texture parameters: standard deviation (ADC ), kurtosis (ADC ), and skewness (ADC ). Additional subanalyses focused on the accuracy of ADC and ADC texture parameters in different lymph node volumes and nodal regions.

Statistical Tests: Benign and malignant nodes were compared using Mann-Whitney U-tests with 18-Fluoro-deoxyglucose positron emission tomography computed tomography and bone marrow biopsy as reference standard. Receiver operating characteristic analyses were performed to determine cutoff values and calculate sensitivity, specificity, accuracy, and positive and negative predictive value (PPV, NPV).

Results: ADC (P = 0.008), ADC and ADC differed significantly between benign and malignant nodes (P < 0.001), while ADC didn't (P = 0.21). ADC was the best discriminating parameter, with 79% sensitivity, 86% specificity, 83% accuracy, 85% PPV, and 81% NPV. In every volume category, ADC yielded the highest accuracy (88% in 0-25 percentile volume, 75% in 25 -75 percentile, 93% in 75-100 percentile). On a per-region basis, ADC accuracy varied 13.6% between nodal regions, while ADC , ADC , and ADC showed interregional variation of 17.4%, 20.3%, and 14.9%, respectively.

Data Conclusion: First-order ADC texture analysis with WB-DWI improved lymph node characterization compared to ADC . ADC was the most accurate and robust discriminatory parameter over all lymph node volumes and nodal body regions.

Level Of Evidence: 3 Technical Efficacy: Stage 2 J. Magn. Reson. Imaging 2018;48:897-906.
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http://dx.doi.org/10.1002/jmri.26034DOI Listing
October 2018

Neoadjuvant degarelix with or without apalutamide followed by radical prostatectomy for intermediate and high-risk prostate cancer: ARNEO, a randomized, double blind, placebo-controlled trial.

BMC Cancer 2018 04 2;18(1):354. Epub 2018 Apr 2.

Urology, Department of Development and Regeneration, University Hospitals Leuven, Leuven, Belgium.

Background: Recent retrospective data suggest that neoadjuvant androgen deprivation therapy can improve the prognosis of high-risk prostate cancer (PCa) patients. Novel androgen receptor pathway inhibitors are nowadays available for treatment of metastatic PCa and these compounds are promising for early stage disease. Apalutamide is a pure androgen antagonist with a very high affinity with the androgen receptor. The combination of apalutamide with degarelix, an LHRH antagonist, could increase the efficacy compared to degarelix alone.

Objective: The primary objective is to assess the difference in proportions of minimal residual disease at prostatectomy specimen between apalutamide + degarelix vs placebo + degarelix. Various secondary endpoints are assessed: variations of different biomarkers at the tumour level (tissue microarrays to evaluate DNA-PKs, PARP, AR and splice variants, PSMA, etc.), whole transcriptome sequencing, exome sequencing and clinical (PSA and testosterone kinetics, early biochemical recurrence free survival, quality of life, safety, etc.) and radiological endpoints.

Methods: ARNEO is a single centre, phase II, randomized, double blind, placebo-controlled trial. The plan is to include at least 42 patients per each of the two study arms. Patients with intermediate/high-risk PCa and who are amenable for radical prostatectomy with pelvic lymph node dissection can be included. After signing an informed consent, every patient will undergo a pelvic Ga -PSMA-11 PSMA PET/MR and receive degarelix at standard dosage and start assuming apalutamide/placebo (60 mg 4 tablets/day) for 12 weeks. Within thirty days from the last study medication intake the same imaging will be repeated. Every patient will undergo PSA and testosterone testing the day of randomization, before the first drug intake, and after the last dose. Formalin fixed paraffin embedded tumour samples will be collected and used for transcriptome analysis, exome sequencing and immunohistochemistry.

Discussion: ARNEO will allow us to answer, first, whether the combined treatment can result in an increased proportion of patients with minimal residual disease. Secondly, It will enable the study of the molecular consequences at the level of the tumour. Thirdly, what the consequences are of new generation androgen receptor pathway inhibitors on Ga -PSMA-11 PET/MR. Finally, various clinical, safety and quality of life data will be collected.

Trial Registration: EUDRaCT number: 2016-002854-19 (authorization date 3rd August 2017). clinicalTrial.gov: NCT03080116 .
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http://dx.doi.org/10.1186/s12885-018-4275-zDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5879743PMC
April 2018

Molecular Subtypes of Clear-cell Renal Cell Carcinoma are Prognostic for Outcome After Complete Metastasectomy.

Eur Urol 2018 10 17;74(4):474-480. Epub 2018 Feb 17.

Laboratory of Experimental Oncology, Department of Oncology, KU Leuven, Leuven, Belgium; Inserm, UMR-1162, Génomique Fonctionnelle des Tumeurs Solides, IUH, Paris, France; Department of General Medical Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium. Electronic address:

Background: Metastasectomy is routinely performed in selected patients with metastatic clear-cell renal cell carcinoma (ccRCC) as an alternative to systemic therapy. In the absence of randomized trials, the benefit and best way of patient selection remain unclear. Earlier, we described four molecular ccRCC-subtypes (ccrcc1-4) that have a prognostic and predictive value upon first-line sunitinib or pazopanib.

Objective: Assess the prognostic value of ccrcc1-4 subtypes after complete metastasectomy. (1) Compare outcomes of good-prognosis ccrccc2&3-tumors with intermediate/poor-prognosis ccrcc1&4-tumors. (2) Compare outcomes of the four subtypes separately.

Design, Setting, And Participants: Single-center retrospective study (1995-2017), assessing 43 ccRCC patients undergoing complete metastasectomy without systemic treatment.

Intervention: Molecular subtype determined with established 35-gene expression classifier.

Outcome Measurements And Statistical Analysis: Median disease-free survival (DFS), time to systemic therapy, cancer-specific (CSS) and overall survival (OS) from metastasectomy, estimated with Kaplan-Meier method and tested against other predictors with multivariable Cox regression.

Results And Limitations: Median DFS was 23 mo for ccrcc2&3-tumors versus 9 mo for ccrcc1&4-tumors (p=0.011, hazard ratio [HR]=2.6). Median time to systemic therapy was 92 mo versus 28 mo (p=0.003, HR=3.3). Median CSS was 133 mo versus 50 mo (p<0.001, HR=2.7). Median OS was 127 mo versus 50 mo (p=0.011, HR=2.5). The classification remained independent upon multivariable analysis. Outcomes remained significantly different when comparing four subtypes separately. The intrinsic heterogeneity of expression profiles is a limitation of this approach.

Conclusion: Even after clinical patient selection, patients with a ccrcc1- or ccrcc4-tumor are at a higher risk of relapse after complete metastasectomy. Patients with a ccrcc2- or ccrcc3-tumor usually experience a long DFS. These results need validation in a larger cohort to establish the subtypes as prognostic marker.

Patient Summary: Metastasectomy is recommended for some patients with metastatic clear-cell kidney cancer; however, we do not know who will benefit the most. We show that molecular subtypes increase the possibility to predict which patients are at risk for early relapse after metastasectomy and who may benefit more from other treatment options.
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http://dx.doi.org/10.1016/j.eururo.2018.01.042DOI Listing
October 2018
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