Clinical Studies Overview
Research into breast cancer must continue until a cure is found. This includes new tools to diagnose the disease or to monitor treatment. All women who are affected by breast cancer should consider volunteering for clinical trials, which are a way to test new ideas and treatments.
Over the last few decades, such volunteers have helped researchers learn so much that women with breast cancer today receive significantly better treatment than in the past. But there is still more to be done…
At present, SoftScan is approved for sale in Canada and Europe. As part of its submission to the FDA that will lead to approval for sales in the U.S., ART continues to pursue enrollment for its pivotal clinical study at North American sites. This pivotal study examines 600 to 950 women aged 25 and older, to determine the clinical safety of the device and its effectiveness in imaging breast tissue.
Other clinical studies for SoftScan include design optimization (engineering) and tissue characterization studies. Interim data from clinical studies published in Academic Radiology demonstrates SoftScan’s capacity to discriminate between malignant and benign breast lesions based on their deoxy-hemoglobin content.