Diagnostic imaging  

Clinical trials of SoftScan optical breast imaging system at Toronto hospital

Montreal, Canada. Advanced Research Technologies Inc. (ART) (TSX: ARA), a Canadian medical device company and a leader in optical molecular imaging products for the healthcare and pharmaceutical industries, today announced that it is undertaking clinical trials at Toronto's Princess Margaret Hospital as part of its North American pivotal study for the SoftScan optical breast imaging system.

"This study will give access to an important pool of volunteer patients from hospitals such as Mount Sinai Hospital and Princess Margaret Hospital, and contribute to the success of clinical trials now underway across Canada and the US," explained Ms. Micheline Bouchard, President and CEO of ART Advanced Research Technologies Inc. "The completion of pivotal trials will open the way for the commercialization of this molecular imaging technology whose potential applications continue to grow."

Princess Margaret Hospital is joining other renowned medical centres such as the Cedars Breast Clinic of the McGill University Health Centre, the Centre Hospitalier de l'Université de Montréal, the Central Alberta Medical Imaging Services and the Massachusetts General Hospital, in bringing the SoftScan device to market. Indeed, this study represents the final stage prior to commercializing SoftScan, an optical breast imaging system designed to improve the diagnosis and treatment of breast cancer. ART intends to present results of the study in its submission to Health Canada and the U.S. Food and Drug Administration (FDA) to support its pre-market approval application for SoftScan®.

"Although mammography is the primary clinical imaging modality used to detect breast cancer, limitations in both sensitivity and specificity, particularly in younger and high-risk women, have led to the development of alternative techniques. Optical methods are advantageous because they are non-invasive, and pose no risk of ionizing radiation. Differences in optical signatures between tissues are manifestations of multiple physiological changes associated with factors such as vascularization, cellularity, oxygen consumption, edema, fibrosis, and remodelling. The current study will provide critical information regarding the possible clinical applications of SoftScan for early cancer detection and for distinguishing between malignant and benign tumors," said Dr. Pavel Crystal, Principal Investigator and Assistant Professor of Radiology at the University of Toronto.

Developed in Canada, 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 and pain-free approach uses time-domain optical imaging technology, capable of precision characterization of benign and malignant breast tumours, while maintaining the patient's well-being.

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 real conditions of use. This study will be conducted at Princess Margaret Hospital, part of University Health Network, and at the McGill University Health Centre (MUHC), as well as in additional major centres in North America to be announced in the upcoming months.

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