Study Initiated To Determine whether adding CAD to CT Colonography Increases Cancer Detection Over CT Colonography Alone

A multi-reader clinical study has been designed to determine whether the addition of a computer-aided detection (CAD) system to computed tomography (CT) colonography would increase detection rates of colon cancer instead of using only CT colonography.

The American College of Radiology (ACR; Restin, VA, USA) Image Metrix will conduct the trail using a CAD system developed by iCAD, Inc. (Nashua, NH, USA). The CT Colon CAD system enables radiologists interpreting CT colonography images to detect more tumors than they would without utilizing the iCAD system in the image interpretation process. ACR Image Metrix will work with iCAD to develop and execute a clinical study to support U.S. Food and Drug Administration (FDA) approval of CT Colon CAD.

"ACR Image Metrix is proud to undertake such an important study. CT colonography is a cutting-edge technology that has the potential to save countless thousands of lives when effectively utilized. It is important to know whether adjunct technologies such as CAD can help make CT colonography even more effective at detecting colorectal cancer, the nation's second leading cancer killer,” said Bruce J. Hillman, M.D., FACR, ACR Image Metrix director of scientific affairs.

CT Colonography employs sophisticated, virtual reality technology to produce three-dimensional, "fly through” images that allow a thorough and minimally invasive evaluation of the entire colorectal structure for cancer and precancerous polyps. CAD computer software would then search the CT images obtained for abnormal areas of density or mass that may indicate the presence of cancer and precancerous polyps. The CAD system highlights these areas on the images, alerting the radiologists to the possible need for further analysis.

"This partnership represents a major step forward in the development of our Colon CAD product,” said Ken Ferry, president and chief executive officer of iCAD. "We feel that working with ACR Image Metrix, a group with significant expertise in radiology clinical trial management, will put us in an optimal position to submit solid clinical data to FDA and meet our goals for this important product line.”

Colorectal cancer is the third most frequently diagnosed cancer and second leading cause of cancer death in men and women in the United States. However, despite the known benefits of screening, studies indicate that the majority of the 82 million individuals in the United States aged 50 and older are not being screened for the disease.

The recently presented results of the American College of Radiology Imaging Network's National CT Colonography Trial, along with a number of published studies, indicate that CT colonography is a viable colorectal cancer screening alternative and less invasive than the "gold standard" optical colonoscopy. "It is clear from the low compliance levels that we need more options in colon cancer screening,” said Dr. Hillman. "We feel that CT colonography has the potential to drastically improve colon cancer screening, and we look forward to exploring how CAD can impact and enhance this new option for detecting cancer.”

ACR Image Metrix is a contract research organization headquartered in the ACR Philadelphia (PA, USA) office, alongside ACR's clinical research division. The ACR research division, on whose successes ACR Image Metrix is based, has conducted more than 500 clinical trials involving as many as 50,000 patients and handled more than 50 million medical images.

iCAD is a provider of CAD systems that enable healthcare professionals to identify pathologies and pinpointing cancer earlier. iCAD provides a comprehensive range of high-performance, upgradeable CAD systems for the high, mid-, and low volume mammography markets.


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