Canadian medical device company ART Advanced Research Technologies Inc. recently unveiled plans for clinical trials at the Moores Cancer Center, University of California, San Diego, in La Jolla, as part of its North American pivotal study for the SoftScan optical breast imaging system.
"We are pleased to work with ART on this important new imaging modality which has the potential to improve the diagnosis and effective treatment of breast cancer,” said Christopher Comstock, MD, principal investigator and section chief of breast imaging, Department of Radiology, UCSD. “We believe in the potential of optical imaging and its application to both preclinical and clinical research and have made it a key area for our own research."
Other participating medical centers include Cedars Breast Clinic of the McGill University Health Centre, the Centre Hospitalier de l'Université de Montréal, the Central Alberta Medical Imaging Services, the UHN Princess Margaret Hospital, and the Massachusetts General Hospital, in bringing the SoftScan device to market.
This study represents the final stage prior to commercializing SoftScan. ART intends to present results of the study in its submission to Health Canada and the U.S. FDA to support its pre-market approval application for SoftScan.
SoftScan has been designed first as a complementary diagnostic tool to mammography, to be ultimately used for the detection and treatment monitoring of breast cancer. Its non-invasive approach uses time-domain optical imaging technology, which could lead to improved characterization of breast tumors as benign or malignant.
The study will extend through 2006 and will examine 600 to 950 women aged 25 to 60 and older. It will assess the clinical safety of the device and its effectiveness under conditions of actual use.