The Role of Clinical Studies in Imaging Validation

Clinical trials play a central role in evaluating the safety and efficacy of many therapeutic products, including pharmaceuticals as well as medical devices. But such studies are also valuable when it comes to assessing the utility of diagnostic strategies made possible by the latest generations of medical imaging technologies. Today, companies in the medical imaging sector are embracing the use of clinical trials as a critical obligation for bringing new products to market.

Toshiba’s CorE 64 clinical trial compares the clinical benefits of coronary CT angiography (top) with cardiac catheterization (bottom).

In 2004, working with partners around the world, Toshiba launched its coronary evaluation on 64-slice CT (CorE 64) study, the industry’s first multicenter clinical study to investigate the use of 64-row multislice computed tomography (CT) as the primary diagnostic tool for the detection of cardiovascular diseases and disorders. Using Toshiba’s Aquilion 64, the study will evaluate whether today’s CT technology could replace diagnostic cardiac catheterization as the gold standard in cardiac imaging.

The CorE 64 investigating partners include Johns Hopkins University School of Medicine (Baltimore); Beth Israel Deaconess Medical Center, Harvard Medical School (Boston); Humboldt University, Campus Charite Mitte (Berlin); Iwate Medical University (Iwate, Japan); Toronto General Hospital, University Health Network (Toronto); and Mount Sinai Hospital (Toronto). More than 300 patients have been enrolled, and results are expected sometime in 2007.