Clinical trials of SoftScan optical breast imaging system at Toronto
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.