KEY LARGO, FL - Optical molecular imaging developer ART Advanced Research Technologies has enrolled 320 patients in phase III of a 950-person clinical trial for SoftScan, currently under way at several Canadian institutions.
At the Breast Course 2007, George Desypris, Ph.D, director of clinical operations for ART, told AuntMinnie.com that ART hoped to have data from the trial analyzed by the end of this year and subsequently file an application with the U.S. Food and Drug Administration in 2008. In February, the Montreal-based vendor received the European CE Mark for its optical breast imaging device.
The SoftScan trial is being done at Central Alberta Medical Imaging Services in Red Deer and at centers in Toronto and Montreal. Margaret Polyzos, ART's manager of clinical research, said that mammography technologists currently using the system have made positive comments about its ease of use.
SoftScan is not intended to replace mammography or biopsy, but to serve as an additional diagnostic tool, especially in cases in which mammography results are equivocal or in women who do not benefit from traditional imaging, such as those with dense breasts and a family history, Desypris said. The company is also looking at SoftScan's abilities as a noninvasive tool for breast cancer treatment monitoring, he said.
By AuntMinnie.com staff writers
March 12, 2007
Related Reading
ART lands CE Mark, February 8, 2007
ART, GE extend eXplore Optix pact, December 22, 2006
ART gets Health Canada approval for SoftScan, December 14, 2006
ART completes financing, corporate reorganization, November 29, 2006
ART repurchases debentures, November 21, 2006
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