Publications by authors named "David Vining"

17 Publications

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Multispecialty Enterprise Imaging Workgroup Consensus on Interactive Multimedia Reporting Current State and Road to the Future: HIMSS-SIIM Collaborative White Paper.

J Digit Imaging 2021 Jun 15;34(3):495-522. Epub 2021 Jun 15.

Lead CT Radiologist, NIH Clinical Center, Bethesda, MD, USA.

Diagnostic and evidential static image, video clip, and sound multimedia are captured during routine clinical care in cardiology, dermatology, ophthalmology, pathology, physiatry, radiation oncology, radiology, endoscopic procedural specialties, and other medical disciplines. Providers typically describe the multimedia findings in contemporaneous electronic health record clinical notes or associate a textual interpretative report. Visual communication aids commonly used to connect, synthesize, and supplement multimedia and descriptive text outside medicine remain technically challenging to integrate into patient care. Such beneficial interactive elements may include hyperlinks between text, multimedia elements, alphanumeric and geometric annotations, tables, graphs, timelines, diagrams, anatomic maps, and hyperlinks to external educational references that patients or provider consumers may find valuable. This HIMSS-SIIM Enterprise Imaging Community workgroup white paper outlines the current and desired clinical future state of interactive multimedia reporting (IMR). The workgroup adopted a consensus definition of IMR as "interactive medical documentation that combines clinical images, videos, sound, imaging metadata, and/or image annotations with text, typographic emphases, tables, graphs, event timelines, anatomic maps, hyperlinks, and/or educational resources to optimize communication between medical professionals, and between medical professionals and their patients." This white paper also serves as a precursor for future efforts toward solving technical issues impeding routine interactive multimedia report creation and ingestion into electronic health records.
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http://dx.doi.org/10.1007/s10278-021-00450-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8329131PMC
June 2021

Prolonged response to treatment based on cell-free DNA analysis and molecular profiling in three patients with metastatic cancer: a case series.

Ther Adv Med Oncol 2021 24;13:17588359211001538. Epub 2021 Mar 24.

Department of Investigational Cancer Therapeutics, Phase I Clinical Trials Program, The University of Texas MD Anderson Cancer Center, Unit 455, 1515 Holcombe Boulevard, Houston, TX 77030, USA.

Background: Patients with advanced and/or metastatic solid tumors have limited treatment options. Mutations that serve as biomarkers of carcinogenesis can be found in cell-free DNA of patients' plasma. Analysis of circulating tumor DNA (ctDNA) was developed as a non-invasive, cost-effective alternative to tumor biopsy when such biopsy is not technically feasible or it is associated with high risk for complications. The role of ctDNA in precision oncology is promising but its clinical significance across tumor types remains to be validated. We report a case series of three heavily pretreated patients with advanced solid tumors who received matched targeted therapy based on ctDNA analysis and/or tumor molecular profiling.

Case Presentation: Three patients with advanced, metastatic cancer and the following characteristics are presented: a 71-year-old woman with ovarian cancer and mutation identified in ctDNA and tumor tissue was treated with a PARP inhibitor and achieved partial response by RECIST (Response Evaluation Criteria in Solid Tumors) for 22.6+ months; a 40-year-old woman with adenoid cystic carcinoma of the parotid gland was treated with a MEK/RAF pathway inhibitor on the basis of amplification on ctDNA analysis and had stable disease for 20.2 months; and a 56-year-old woman with breast cancer and a mutation identified by ctDNA analysis was treated with a PARP inhibitor and achieved stable disease for 9.1 months. All three patients are alive at the time of this report.

Conclusions: These results suggest that ctDNA analysis can contribute to selection of targeted therapy in patients with advanced, metastatic cancer. Prospective clinical trials to evaluate and optimize ctDNA biomarkers, as well as the integration of novel and/or alternative targeted therapies, are warranted to fully assess the role of ctDNA analysis in cancer therapy.

Trial Registration: www.clinicaltrials.gov (NCT02152254). Registered May 28, 2014. https://www.clinicaltrials.gov/ct2/show/NCT02152254. MD Anderson protocol # PA12-1161 (approval ID IRB1 FWA00000121) and # PA11-0377 (approval ID IRB4 FWA00005015).
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http://dx.doi.org/10.1177/17588359211001538DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8107674PMC
March 2021

Preclinical Development and First-in-Human Study of KA2507, a Selective and Potent Inhibitor of Histone Deacetylase 6, for Patients with Refractory Solid Tumors.

Clin Cancer Res 2021 Jul 4;27(13):3584-3594. Epub 2021 May 4.

The University of Texas MD Anderson Cancer Center, Houston, Texas.

Purpose: Inhibition of histone deacetylase 6 (HDAC6) is predicted to deliver both direct antitumor activity and modulation of the antitumor immune response. This study describes the development of a novel HDAC6 inhibitor.

Patients And Methods: KA2507 was characterized in HDAC biochemical and cellular target engagement assays and in preclinical efficacy models of melanoma and colorectal cancer. In a phase I study, KA2507 was administered orally using a 3+3 dose-escalation design (NCT03008018).

Results: KA2507 is a potent and selective inhibitor of HDAC6 (biochemical IC = 2.5 nmol/L). Preclinical models demonstrated antitumor efficacy in syngeneic tumor-bearing mice, with translational studies highlighting modulation of the antitumor immune response. Twenty patients were treated in a phase I study. KA2507 was well tolerated; dose-limiting toxicity was not observed up to the maximum dose administered. Pharmacokinetic profiling supported twice-daily oral dosing. Pharmacodynamic analysis demonstrated selective HDAC6 target engagement in peripheral blood cells, free from off-target class I HDAC activity. Stable disease was the best clinical response (7 patients). Three of these patients (adenoid cystic carcinoma, = 2; rectal adenocarcinoma, = 1) had prolonged disease stabilization that lasted for 16.4, 12.6, and 9.0 months, respectively.

Conclusions: KA2507 is a potent and selective inhibitor of HDAC6 showing antitumor efficacy and immune modulatory effects in preclinical models. In a phase I study, KA2507 showed selective target engagement, no significant toxicities, and prolonged disease stabilization in a subset of patients. Further clinical studies of KA2507 are warranted, as a single agent or, preferably, combined with other immuno-oncology drugs.
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http://dx.doi.org/10.1158/1078-0432.CCR-21-0238DOI Listing
July 2021

Precision medicine: preliminary results from the Initiative for Molecular Profiling and Advanced Cancer Therapy 2 (IMPACT2) study.

NPJ Precis Oncol 2021 Mar 19;5(1):21. Epub 2021 Mar 19.

The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Houston, TX, USA.

Precision medicine is associated with favorable outcomes in selected patients with cancer. Herein, we report an interim analysis of IMPACT2, an ongoing randomized study evaluating genomic profiling and targeted agents in metastatic cancer. Patients with metastatic cancer underwent tumor genomic profiling (ClinialTrials.gov: NCT02152254), and 69 patients met the criteria for randomization. Tumor board and multidisciplinary review of molecular alterations optimized treatment selection. From 5/2014 to 4/2017, 320 patients (median age, 63 years; men, 47%) had tumor molecular aberrations, and 213 (66.56%) received anticancer therapy. The most frequently mutated genes were TP53 (42%), KRAS (16%), PIK3CA (12%), and CDKN2A (11%). The median OS was 10.9 months (95% CI, 8.8-12.9). OS was shorter in patients with higher tumor mutational burden. Independent factors associated with shorter OS were age ≥60 years, liver metastases, low albumin levels, high LDH levels, and KRAS and TP53 mutations. Outcomes for randomized patients will be reported after completion of the study.
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http://dx.doi.org/10.1038/s41698-021-00159-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7979841PMC
March 2021

A phase I clinical trial of hepatic arterial infusion of oxaliplatin and oral capecitabine, with or without intravenous bevacizumab, in patients with advanced cancer and predominant liver involvement.

Cancer Chemother Pharmacol 2018 11 4;82(5):877-885. Epub 2018 Sep 4.

Department of Investigational Cancer Therapeutics, Unit 455, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA.

Background: We investigated hepatic arterial infusion (HAI) oxaliplatin combined with capecitabine +/- bevacizumab in advanced cancer with predominant liver involvement.

Methods: Patients received HAI oxaliplatin (140 mg/m) and escalating doses of capecitabine (500, 750, and 1000 mg/m), with (Group 1) or without (Group 2) bevacizumab (10 mg/kg IV). A 3 + 3 dose design was used, followed by an expansion phase.

Results: From 9/2009 to 2/2014, 61 patients (34 men, 27 women) were enrolled (Group 1 = 44; Group 2 = 17). Patients were treated in Group 2 if they had contraindications to bevacizumab (n = 13) or if there was no opening in Group 1 (n = 4). The median age was 60 years (range, 20-88). The most common cancers were colorectal (22 patients), liver (12), pancreatic (7), breast (4), and biliary tract (4). The median number of prior therapies was 3 (range, 1-12); 32 (53%) patients had received oxaliplatin. The dose-limiting toxicity was Grade 3 diarrhea and occurred in 2 patients receiving 1000 mg/m capecitabine. The maximum tolerated dose was HAI oxaliplatin 140 mg/m, capecitabine 750 mg/m, and bevacizumab 10 mg/kg. The most common toxicities were nausea/vomiting, anemia, thrombocytopenia, neutropenia, and hypomagnesemia. The rates of partial response and stable disease ≥ 4 months were 22% and 39% (Group 1) and 9% and 0% (Group 2). The respective median time to treatment failure and overall survival were 3 and 6.9 months (Group 1) and 1.5 and 5.9 months (Group 2).

Conclusion: HAI oxaliplatin combined with capecitabine +/- bevacizumab was well-tolerated and was associated with favorable outcomes in selected patients.
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http://dx.doi.org/10.1007/s00280-018-3680-yDOI Listing
November 2018

Comparative study of computational visual attention models on two-dimensional medical images.

J Med Imaging (Bellingham) 2017 Apr 10;4(2):025503. Epub 2017 May 10.

The University of Texas at Austin, Biomedical Engineering, Austin, Texas, United States.

Computational modeling of visual attention is an active area of research. These models have been successfully employed in applications such as robotics. However, most computational models of visual attention are developed in the context of natural scenes, and their role with medical images is not well investigated. As radiologists interpret a large number of clinical images in a limited time, an efficient strategy to deploy their visual attention is necessary. Visual saliency maps, highlighting image regions that differ dramatically from their surroundings, are expected to be predictive of where radiologists fixate their gaze. We compared 16 state-of-art saliency models over three medical imaging modalities. The estimated saliency maps were evaluated against radiologists' eye movements. The results show that the models achieved competitive accuracy using three metrics, but the rank order of the models varied significantly across the three modalities. Moreover, the model ranks on the medical images were all considerably different from the model ranks on the benchmark MIT300 dataset of natural images. Thus, modality-specific tuning of saliency models is necessary to make them valuable for applications in fields such as medical image compression and radiology education.
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http://dx.doi.org/10.1117/1.JMI.4.2.025503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5424839PMC
April 2017

CT Imaging Findings of Metastatic Spindle Cell Sarcoma of Prostate: A Case Report and Review of the Literature.

Eurasian J Med 2015 Jun 26;47(2):145-50. Epub 2014 Aug 26.

Department of Diagnostic Radiology, Division of Diagnostic Imaging, Univesity of Texas, MD Anderson Cancer Center, Texas, USA.

Sarcomas of the prostate are rare tumors. Imaging plays an important role in the management and diagnosis of patients with prostate sarcomas. Their clinic-pathologic features are well described, but the imaging features of these tumors have rarely been documented in the literature and have appeared mainly as case reports. Herein, we present a rare case of metastatic spindle cell sarcoma of prostate with computed tomography imaging findings.
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http://dx.doi.org/10.5152/eurasianjmed.2014.43DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4494551PMC
June 2015

In vivo CT dosimetry during CT colonography.

AJR Am J Roentgenol 2014 Apr;202(4):703-10

1 Department of Imaging Physics, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030.

Objective: The purpose of this study was to develop a method of measuring rectal radiation dose in vivo during CT colonography (CTC) and assess the accuracy of size-specific dose estimates (SSDEs) relative to that of in vivo dose measurements.

Materials And Methods: Thermoluminescent dosimeter capsules were attached to a CTC rectal catheter to obtain four measurements of the CT radiation dose in 10 volunteers (five men and five women; age range, 23-87 years; mean age, 70.4 years). A fixed CT technique (supine and prone, 50 mAs and 120 kVp each) was used for CTC. SSDEs and percentile body habitus measurements were based on CT images and directly compared with in vivo dose measurements.

Results: The mean absorbed doses delivered to the rectum ranged from 8.8 to 23.6 mGy in the 10 patients, whose mean body habitus was in the 27th percentile among American adults 18-64 years old (range, 0.5-67th percentile). The mean SSDE error was 7.2% (range, 0.6-31.4%).

Conclusion: This in vivo radiation dose measurement technique can be applied to patients undergoing CTC. Our measurements indicate that SSDEs are reasonable estimates of the rectal absorbed dose. The data obtained in this pilot study can be used as benchmarks for assessing dose estimates using other indirect methods (e.g., Monte Carlo simulations).
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http://dx.doi.org/10.2214/AJR.13.11092DOI Listing
April 2014

Virtual colonoscopy: Utility, impact and overview.

World J Radiol 2013 Mar;5(3):61-7

Dhakshina Ganeshan, Khaled M Elsayes, David Vining, Department of Radiology, University of Texas, MD Anderson Cancer Center, Houston, TX 77030, United States.

Computed tomography (CT) colonoscopy is a well-established technique for evaluation of colorectal cancer. Significant advances have been made in the technique of CT colonoscopy since its inception. Excellent results can be achieved in detecting both colorectal cancer and significant sized polyps as long as a meticulous technique is adopted while performing CT colonoscopy. Furthermore, it is important to realize that there is a learning curve involved in interpreting these studies and adequate experience is essential to achieve high sensitivity and specificity with this technique. Indications, contraindications, technique and interpretation, including potential pitfalls in CT colonoscopy imaging, are reviewed in this article. Recent advances and the current role of CT colonoscopy in colorectal cancer screening are also discussed.
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http://dx.doi.org/10.4329/wjr.v5.i3.61DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3650206PMC
March 2013

Effects of patupilone on the pharmacokinetics and pharmacodynamics of warfarin in patients with advanced malignancies: a phase I clinical trial.

Mol Cancer Ther 2011 Jan;10(1):209-17

Corresponding Author: Apostolia M. Tsimberidou, The University of Texas MD Anderson Cancer Center, Department of Investigational Cancer Therapeutics, Unit 455, 1515 Holcombe Boulevard, Houston, TX 77030, USA.

Patupilone is a novel microtubule-targeting cytotoxic agent, which exerts its antitumor effect through microtubule stabilization. Pharmacokinetics, pharmacodynamics, and safety of warfarin when administered concomitantly with patupilone were investigated, and antitumor activity was assessed. This was a phase I, two-center, drug-drug interaction study. In the core phase of the study, treatment consisted of warfarin 20 mg orally (days 1 and 29) and patupilone 10 mg/m(2) i.v. (days 8 and 29). Patients benefiting from patupilone treatment continued treatment every 3 weeks (extension phase) until progression of disease, death, or unacceptable toxicity. Seventeen patients were treated (core phase, 17; extension, 9). The geometric mean ratios (comedication/monotherapy) for C(max) and area under the curve(0-168) of warfarin were near unity and their 90% confidence intervals were within the equivalence limits of 0.80 and 1.25. The half-life, plasma clearance, and International Normalized Ratio (INR) of warfarin were not affected by patupilone coadministration. The most common adverse events were diarrhea, nausea, vomiting, abdominal pain, anorexia, dehydration, asthenia, and peripheral neuropathy. Five (29.4%) patients experienced grade 3 study drug-related adverse events (diarrhea, 17.6%; increased INR, 11.8%; dehydration, 5.9%; and neutropenia, 5.9%). One patient with triple-negative breast cancer (estrogen receptor, progesterone receptor, and HER2/neu negative) had a partial response (35% decrease in tumor measurements by Response Evaluation Criteria in Solid Tumors), and 11 had stable disease for 6 weeks or more (≥12 weeks, 6 patients). The pharmacokinetics and pharmacodynamics of warfarin were not affected by patupilone coadministration, suggesting that patupilone has no clinically relevant effect on CYP2C9 metabolism. Patupilone showed antitumor activity in triple-negative breast cancer.
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http://dx.doi.org/10.1158/1535-7163.MCT-10-0774DOI Listing
January 2011

Extracolonic findings at virtual colonoscopy: an important consideration in asymptomatic colorectal cancer screening.

J Gen Intern Med 2009 Jan 29;24(1):69-73. Epub 2008 Oct 29.

Section on Gastroenterology, Wake Forest University School of Medicine, Winston-Salem, NC 27157, USA.

Background: Virtual colonoscopy has been evaluated for use as a colorectal cancer screening tool, and in prior studies, it has been estimated that the evaluation of extra-colonic findings adds $28-$34 per patient studied.

Methods: As an ancillary study to a prospective cohort study comparing virtual colonoscopy to conventional colonoscopy for colorectal cancer detection, the investigators retrospectively determined the number and estimated costs of all clinic visits, imaging and laboratory studies, and medical procedures that were generated as a direct result of extra-colonic findings at virtual colonoscopy.

Results: We enrolled 143 subjects who underwent CTC followed by conventional colonoscopy. Data were available for 136 subjects, and 134 (98%) had at least one extra-colonic finding on CT. Evaluation of extra-colonic findings was performed in 32 subjects (24%). These subjects underwent 73 imaging studies, 30 laboratory studies, 44 clinic visits, 6 medical procedures, and 44 new or return outpatient visits over a mean of 38 months following the CTC. The most common findings causing further evaluation were lung nodules and indeterminate kidney lesions. No extra-colonic malignancies were found in this study. A total of $33,690 was spent in evaluating extra-colonic findings, which is $248 per patient enrolled.

Conclusions: The cost of the evaluation of extra-colonic findings following virtual colonoscopy may be much higher in actual practice than is suggested by prior studies. This will impact the cost-effectiveness of using virtual colonoscopy for asymptomatic colorectal cancer screening and underscores the importance of standardizing the reporting of extra-colonic findings to encourage appropriate follow-up.
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http://dx.doi.org/10.1007/s11606-008-0835-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2607491PMC
January 2009

Segmentation in virtual colonoscopy using a geometric deformable model.

Comput Med Imaging Graph 2006 Jan 18;30(1):17-30. Epub 2006 Jan 18.

Wake Forest University School of Medicine, Medical Centre Boulevard, Winston-Salem, NC, USA.

The Geometric Deformable Model is developed for accurate colon lumen segmentation as part of an automatic Virtual Colonoscopy system. The deformable model refines the lumen surface found by an automatic seed location and thresholding procedure. The challenges to applying the deformable model are described, showing the definition of the stopping function as the key to accurate segmentation. The limitations of current stopping criteria are examined and a new definition, tailored to the task of colon segmentation, is given. First, a multiscale edge operator is used to locate high confidence boundaries. These boundaries are then integrated into the stopping function using a distance transform. The hypothesis is that the new stopping function results in a more accurate representation of the lumen surface compared to previous monotonic functions of the gradient magnitude. This hypothesis is tested using observer ratings of colon surface fidelity at 100,000 randomly selected locations in each of four datasets. The results show that the surfaces determined by the modified deformable model better represent the lumen surface overall.
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http://dx.doi.org/10.1016/j.compmedimag.2005.07.003DOI Listing
January 2006

Computed tomographic colonography (virtual colonoscopy): a multicenter comparison with standard colonoscopy for detection of colorectal neoplasia.

JAMA 2004 Apr;291(14):1713-9

Department of Gastroenterology, The Digestive Disease Center, Medical University of South Carolina, Charleston 29425, USA.

Context: Conventional colonoscopy is the best available method for detection of colorectal cancer; however, it is invasive and not without risk. Computed tomographic colonography (CTC), also known as virtual colonoscopy, has been reported to be reasonably accurate in the diagnosis of colorectal neoplasia in studies performed at expert centers.

Objective: To assess the accuracy of CTC in a large number of participants across multiple centers.

Design, Setting, And Participants: A nonrandomized, evaluator-blinded, noninferiority study design of 615 participants aged 50 years or older who were referred for routine, clinically indicated colonoscopy in 9 major hospital centers between April 17, 2000, and October 3, 2001. The CTC was performed by using multislice scanners immediately before standard colonoscopy; findings at colonoscopy were reported before and after segmental unblinding to the CTC results.

Main Outcome Measures: The sensitivity and specificity of CTC and conventional colonoscopy in detecting participants with lesions sized at least 6 mm. Secondary outcomes included detection of all lesions, detection of advanced lesions, possible technical confounders, participant preferences, and evidence for increasing accuracy with experience.

Results: A total of 827 lesions were detected in 308 of 600 participants who underwent both procedures; 104 participants had lesions sized at least 6 mm. The sensitivity of CTC for detecting participants with 1 or more lesions sized at least 6 mm was 39.0% (95% confidence interval [CI], 29.6%-48.4%) and for lesions sized at least 10 mm, it was 55.0% (95% CI, 39.9%-70.0%). These results were significantly lower than those for conventional colonoscopy, with sensitivities of 99.0% (95% CI, 97.1%->99.9%) and 100%, respectively. A total of 496 participants were without any lesion sized at least 6 mm. The specificity of CTC and conventional colonoscopy for detecting participants without any lesion sized at least 6 mm was 90.5% (95% CI, 87.9%-93.1%) and 100%, respectively, and without lesions sized at least 10 mm, 96.0% (95% CI, 94.3%-97.6%) and 100%, respectively. Computed tomographic colonography missed 2 of 8 cancers. The accuracy of CTC varied considerably between centers and did not improve as the study progressed. Participants expressed no clear preference for either technique.

Conclusions: Computed tomographic colonography by these methods is not yet ready for widespread clinical application. Techniques and training need to be improved.
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http://dx.doi.org/10.1001/jama.291.14.1713DOI Listing
April 2004

Virtual colonoscopy using oral contrast compared with colonoscopy for the detection of patients with colorectal polyps.

Gastroenterology 2003 Aug;125(2):304-10

Department of Internal Medicine, Section of Gastroenterology, Wake Forest University School of Medicine, Medical Center Boulevard, Winston-Salem, North Carolina 27157 USA.

Background & Aims: Virtual colonoscopy using abdominal spiral computed tomography scanning allows total colonic evaluation with minimal invasiveness. Two-dimensional images and selective 3-dimensional images of the colon are used to detect colorectal lesions. This trial used conventional colonoscopy with segmental unblinding to determine the ability of virtual colonoscopy to identify patients with colorectal lesions who need conventional colonoscopy.

Methods: We studied 205 patients with virtual colonoscopy using oral iodinated contrast preceding conventional colonoscopy. Colonic lavage was achieved with an oral sodium phosphosoda preparation and colonic distention with a carbon dioxide electronic insufflator.

Results: The overall sensitivity and specificity of virtual colonoscopy in identifying patients with colorectal lesions was 61.8% and 70.7%, respectively. Virtual colonoscopy was more accurate in identifying patients with lesions >/=6 mm (sensitivity 84.4% and specificity 83.1%) and those with lesions >/=10 mm (sensitivity 90% and specificity 94.6%). The negative predictive value of virtual colonoscopy was 95% for a 6-mm cutoff size and 98.9% for a 10-mm cutoff. Using a 10-mm cutoff, virtual colonoscopy precludes the need for conventional colonoscopy in 86% of patients with a 1% false-negative rate (68% with a 3.4% false-negative rate when using a 6-mm cutoff).

Conclusions: Virtual colonoscopy has a high sensitivity and specificity for detecting patients with significant colorectal lesions. Its high negative predictive value may help reduce the number of negative screening colonoscopies. Further studies are needed to determine what lesion cutoff size is clinically acceptable and the appropriate interval time for repeat virtual colonoscopy when it detects lesions below this cutoff size.
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http://dx.doi.org/10.1016/s0016-5085(03)00885-0DOI Listing
August 2003

The virtual colonoscopy study: a large multicenter clinical trial designed to compare two diagnostic screening procedures.

Control Clin Trials 2002 Oct;23(5):570-83

TCIG*STATS, The Clinical Innovation Group, MUSC Foundation for Research and Development, The Medical University of South Carolina, Charleston, SC, USA.

This paper reviews the design of a large multicenter clinical trial currently being conducted to test the equivalence of two screening procedures for colorectal polyps. The primary outcome is the sensitivity and specificity of the new and standard procedures for detecting subjects with and without polyps of a size > or =6 mm, respectively. An important secondary outcome is the accuracy of these procedures in detecting individual polyps. A total of 619 participants underwent virtual colonoscopy, the new procedure, followed by conventional colonoscopy, the standard procedure. Strategies for the design and implementation of the study are shared as well as the challenges encountered.
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http://dx.doi.org/10.1016/s0197-2456(02)00232-5DOI Listing
October 2002

Better tolerance for colonoscopy or intolerance to virtual colonoscopy?

Gastrointest Endosc 2002 Oct;56(4):609-10; author reply 610

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http://dx.doi.org/10.1067/mge.2002.128494DOI Listing
October 2002
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