iCAD, a provider of computer-aided detection (CAD) solutions for the identification of cancer, has initiated a clinical study for Colon CAD, its virtual colonoscopy CAD product, in partnership with ACR Image Metrix, a subsidiary of the American College of Radiology (ACR).
iCAD and ACR Image Metrix are collaborating on study execution including a multi-reader, multi-case (MRMC) clinical study designed to assess the impact of Colon CAD on the accuracy of interpreting CT colonography exams. The study will also assess the sensitivity of Colon CAD for detecting polyps and will measure the impact of iCAD’s CT Colon CAD product on interpretation and workflow.
The study, which will be managed and executed by ACR Image Metrix, will include up to 20 radiologists, is expected to take about six months to complete. The radiologists will analyze several hundred cases tested with virtual colonoscopy, featuring Colon CAD.
“Moving to this clinical study, which should enable iCAD to submit the necessary data to the FDA, is an exciting step bringing the company closer to taking our Colon CAD product to market,” said Ken Ferry, president and CEO of iCAD. “Working with ACR Image Metrix, a group with a high level of expertise in this area, will be of great value in helping us prove the tremendous benefits we believe our Colon CAD product can provide both in polyp detection and workflow enhancement.”
Results from recent trials including the National CTC Trial conducted by the ACR Imaging Network (ACRIN) that demonstrated the effectiveness of virtual colonoscopy as a screening procedure, coupled with recent initiatives to establish Medicare reimbursement for the procedure, may increase the viability of virtual colonoscopy for colorectal cancer screening and are likely to drive increased utilization of the procedure.
“CT colonography will not only provide a new and necessary option for cancer detection, but has the potential to increase screening rates nationwide,” said principal investigator Abraham Dachman, MD, professor of radiology at the University of Chicago Medical Center. “While we expect the benefits in polyp detection will be significant, we are also exploring how enhanced workflow features can add to the benefit CAD provides to CT colonography.”