Medicsight's ColonCAD - which has been integrated as part of the Viatronix Inc. V3D-Colon workstation - will be used in the SIGGAR1 clinical trial to interpret CT colonography (virtual colonoscopy) studies. The study will be conducted by Special Interest Group for Gastrointestinal and Abdominal Radiology (SIGGAR), according to a release.
The SIGGAR1 trial is the first randomized comparison where the focus is symptomatic cancer, not screening for polyps, and there is much more patient preference, psychological, modeling, and health economic assessment than other trials to date. Vertec Scientific, a Viatronix U.K. sales and service provider, will install the combined Viatronix/Medicsight imaging systems at all 15 SIGGAR1 trial sites around the U.K. The SIGGAR1 trial will include approximately 4,500 patients, and results are expected to be reported in 2008.
The study aims to compare CT colonography with the two established alternatives, barium enema and optical colonoscopy, for diagnosis of colonic cancer in older symptomatic patients in the United Kingdom. While many studies have shown CT colonography to be very sensitive for colon cancer, the SIGGAR1 trial is the first randomized trial to investigate this modality against traditional colonoscopy and barium enema.
"Our studies strongly suggest that CAD seamlessly integrated into CT colonography software helps to reduce the time needed to report CT colonography while simultaneously improving sensitivity for polyps and cancers. The SIGGAR1 trial offers a significant opportunity to test these findings at multiple sites across multiple observers to see if they are reproducible," said Steve Halligan, professor, principal investigator for SIGGAR1 and consultant radiologist at University College Hospital, London. "It is expected that Viatronix V3D-Colon workstations with integrated Medicsight ColonCAD will be available at some sites early in 2006, when a sub-study of the effect of CAD on the detection of cancers and large polyps (i.e. those possibly responsible for symptoms) will begin in earnest," added Halligan.
The Viatronix V3D-Colon workstation with Medicsight ColonCAD API allows users of the integrated software to simultaneously view Medicsight ColonCAD polyp identification marks while viewing a virtual fly-through of the colon. Filter settings also can be manually altered to suit the user's preference, clinical situation, and experience.
The study is sponsored by the National Health Service (NHS) Health Technology Assessment (HTA) program.