Wednesday, December 3, 2003 Virtual Colonoscopy Proves Up To 96 Percent Effective In Landmark Clinical Trial

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Virtual Colonoscopy Proves Up To 96 Percent Effective In Landmark Clinical Trial Reported In NEJM Non-invasive Technology Was Developed at Stony Brook University

STONY BROOK, N.Y., December 1, 2003—The 3D virtual colonoscopy (VC) technology developed at Stony Brook University shows a sensitivity and specificity that is a significant improvement over other techniques, according to the largest-ever clinical trial utilizing the 3D VC. The results of this landmark trial are reported this week in the New England Journal of Medicine.

The multi-center independent trial was conducted in the National Naval Medical Center, Walter Reed Army Medical Center, and the Naval Medical Center, San Diego. The 1,233 asymptomatic average-risk adults who participated in the study received a virtual colonoscopy examination followed the same day by optical colonoscopy. The 3D VC had a 93.9 percent and 93.8 percent sensitivity for adenomatous polyps greater or equal 8mm and 10mm, respectively, and 92.2 percent and 96.0 percent specificity for adenomatous polyps greater or equal 8mm and 10mm, respectively.

A team of computer-scientists and radiologists at Stony Brook University pioneered the development of 3D VC, an alternative to conventional optical colonoscopy, for screening patients for colonic polyps, the precursor of colon cancer. Unlike optical colonoscopy, VC employs a patient-friendly bowel preparation, and it is a fast, non-invasive, more accurate, and cost-effective procedure for mass colorectal screening.

In VC, the patient’s abdomen is imaged by a computed tomography (CT) scanner during a 40-second breath-hold. A 3D model of the colon is then reconstructed from the CT scan. Visualization software allows the physician to virtually navigate through this 3D model of the colon looking for polyps. The VC technology was transferred to Viatronix, Inc., a premier innovator and market leader in diagnostic 3D imaging software, which has been commercializing the Stony Brook based VC technology.

“This prospective trial, comparing virtual and optical colonoscopy, is the largest conducted to date and the first to evaluate an average-risk screening population,” said Perry J. Pickhardt, M.D., the lead physician of the study. “In contrast to previously published studies, which relied on the 2D views for initial polyp detection, we used the 3D virtual fly through for primary detection. We found the Viatronix V3D-Colon system to be an excellent, minimally invasive tool for colorectal screening. In fact, our results showed a higher sensitivity for virtual colonoscopy than for optical colonoscopy—the ‘gold’ standard— for adenomas 8mm and larger," Dr. Pickhardt added.

“We are gratified that Viatronix V3D-Colon System played a significant role in helping Dr. Pickhardt and his team establish these findings,” said Zaffar Hayat, COO of Viatronix, Inc. “The Stony Brook University based VC technology, the system’s ease of use, and workflow optimized tools all assisted the radiologists in conducting the exam easily and efficiently. This, in itself, exhibits the superior quality of the Viatronix V3D technology,” he said.

“The Stony Brook University VC technology with automatic segmentation, electronic cleansing, real-time volume rendering with superior visualization quality and electronic biopsy, were paramount ingredients in the success of this study,” said Arie Kaufman, Ph.D., Chair of the Computer Science Department, who lead the development team at Stony Brook University. “Following this study, VC is poised to become the procedure of choice for mass screening for colon polyps, the precursor of colon cancer. If all patients 50 years of age and older will participate in such a screening program, over 92 percent of colorectal cancer will be prevented,” Dr. Kaufman said.

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