CT colonography CAD trial could quicken regulatory approval

April 24, 2008

A clinical study to determine computer-aided detection’s value to CT colonography could save manufacturers time and money by speeding up the regulatory approval process. If proven successful, the approach could save thousands of lives each year by enhancing early colorectal cancer detection.

A clinical study to determine computer-aided detection's value to CT colonography could save manufacturers time and money by speeding up the regulatory approval process. If proven successful, the approach could save thousands of lives each year by enhancing early colorectal cancer detection.

ACR Image Metrix, the American College of Radiology's for-profit contract research organization (CRO), announced in January a contract with iCAD to conduct a study to determine the value of CAD for CT colonography exams. The Nashua, NH, company has already obtained FDA market approval for a mammography CAD system and is seeking approval for its CT colonography product.

About 150,000 new cases of colorectal cancer, the second leading cancer killer in the U.S., will be diagnosed this year, according to the National Cancer Institute. A third of them will be fatal. More than 80 million patients are eligible for colonoscopy screening, but compliance remains low, allegedly due to the procedure's invasiveness.

Recent trial results showing the effectiveness of CT colonography screening plus news of possible reimbursement for the procedure may increase CTC utilization and the number of annual colon screening exams. CTC screening has the potential to save lives if it's used properly, but adding CAD could make it even more effective at detecting colorectal cancer, said Dr. Bruce J. Hillman, chief scientific officer for ACR Image Metrix,

In March 2004, the FDA announced its Critical Path Initiative to streamline the approval process for new drugs, biological products, and medical devices. The plan called for a joint effort among academia, industry, and the FDA to turn concepts into safe and effective treatments faster and more cost-effectively without forfeiting scientific rigor. CROs will play a key role in the implementation of this policy, according to FDA and industry insiders.

Traditional CROs provide the scientific infrastructure and paperwork needed to get a drug or device through the regulatory approval process. ACR Image Metrix offers similar services but adds an advanced imaging component to its research protocols, Hillman said.

ACR Image Metrix is managing trials for several pharmaceutical companies that need imaging to determine side effects or end points, such as time to regression or progression-free survival, for their cancer drugs. The iCAD contract represents a breakthrough because CAD is a diagnostic technology, not a therapeutic one, Hillman told Diagnostic Imaging.

"The trial could validate (iCAD's) product for CT colonography as being valuable to patient care," Hillman said.

The ACR ran many successful trials through its Imaging Network for many years. Its one-year-old for-profit subsidiary already has many contracts under its belt but still needs to prove its value to industry, Hillman said.

"This would be an important step in showing that ACR Image Metrix does offer great value to industry, as we expect it will," he said.

Hillman stepped down as ACRIN chair on Dec. 31, 2007, and became the ACR Image Matrix chief scientific officer the next day. His main role is providing scientific oversight to all contracted projects. ACR Image Metrix signed up Dr. Abraham H. Dachman, a professor of radiology at the University of Chicago, as principal investigator in the CTC-CAD trial.

"Our business model is basically to hire the best scientific expertise to aid our clients," Hillman said.

For more information from the Diagnostic Imaging archives:

Imaging research efforts place focus on clinical effectiveness

ACRIN's five-year plan aims to strengthen core labs and expand funding sources

CT colonography matches gold standard in eagerly awaited ACRIN trial results

ACR launches research outsourcing firm