iCAD has launched a postmarketing study to assess the safety and efficacy of the company's Xoft Axxent eBx system when used for single-fraction intraoperative radiation therapy (IORT) at the time of lumpectomy for early-stage breast cancer.
A historical comparison will be made to the current standard of care, external-beam radiation therapy (EBRT). Researchers plan to enroll up to 1,000 patients at as many as 50 study sites across the U.S. and Europe.
Study subjects will be followed for 10 years after treatment to determine the safety and efficacy of IORT with the Xoft system, and interim data will be collected on an annual basis. The study will also assess cosmetic outcomes and quality of life for subjects treated with Xoft IORT, iCAD said.
