FDAnews Device Daily Bulletin

CANADIAN COMPANY BEGINS BREAST IMAGING SYSTEM TRIAL

March 31, 2006
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Quebec-based medical device company ART Advanced Research Technologies has launched a Phase III clinical trial of its SoftScan breast imaging system at Toronto's Princess Margaret Hospital.

The clinical trial is part of the company's North American large-scale pivotal study, currently underway at the McGill University Health Center, the Centre Hospitalier de l'Universite de Montreal, Central Alberta Medical Imaging Services and Boston's Massachusetts General Hospital.

Continuing throughout 2006, the trial will assess the clinical safety and efficacy of the device in 600 to 950 women ages 2560 and older.

SoftScan is a noninvasive, pain-free diagnostic tool that uses time-domain optical imaging technology, which allows for precision characterization of breast tumors.

Contrary to standard mammography, which compresses the patient's breast and uses ionizing radiation to scan for tumors, the SoftScan system involves having the patient lie face-down on a table so that the breast is positioned in an "aquarium" filled with optical liquid below. A laser then emits pulses of near-infrared energy wavelengths into one side of the breast, and detectors collect information about the photons emerging on its other side.

"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," said Pavel Crystal, the study's principal investigator and a professor of radiology at the University of Toronto.

"Optical methods are advantageous because they are noninvasive, 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 remodeling," he said.

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