Leader in cutting edge image analysis, workflow solutions, and radiation therapy, iCAD, Inc., has just announced that over 500 patients have received treatment in an ongoing clinical study of intraoperative radiation therapy (IORT) using their proprietary Xoft Axxent Electronic Brachytherapy (eBx) System. The Xoft System allows a groundbreaking, one-dose technique that precisely delivers radiation to the tumor bed during lumpectomy, thereby protecting surrounding healthy tissue.
Studies have shown performing precision intraoperative radiation therapy (IORT) greatly reduces the need for supplemental post-operative radiotherapy, which yields both health and economic benefits. Over 10,000 cancer patients worldwide have been treated using the Xoft System.
Current available data on the Xoft System shows improvement in quality of life by significantly reducing the number of EBRT treatments from the usual 30-35 daily sessions for 5-7 weeks. The clinical study, titled, “A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft Axxent eBx System at the Time of Breast Conservation Surgery for Early-Stage Breast Cancer (the ExBRT study),” wants to compare the benefits the Xoft System to today’s conventional external beam radiation therapy (EBRT). Patients who enrolled in the study were given a targeted, single-fraction dose using the Xoft System within their lumpectomy procedure.
“We have reached a key milestone in the ExBRT study, the largest IORT clinical study to date using the Xoft System. As IORT gains momentum among patients with early-stage breast cancer, we are seeing a wide range of sites, from large academic institutions to small community medical centers, expanding their breast care programs with the Xoft System,” Ken Ferry, President and CEO of iCAD, Inc., said in a press release. “iCAD is committed to providing advanced treatment options like IORT that have the potential to transform the treatment of cancer for thousands of patients.”
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The researchers are looking to enrol up to 500 more patients across the United States and Europe, in 23 participating centers. Follow-up and observation will be conducted over a span of 10 years following treatment to determine the system’s long-term safety and efficacy profile in breast IORT, along with cosmetic outcomes and effects on overall quality of life.
Co-prinicpal investigator, Helena Chang, M.D., Ph.D. from the University of California Los Angeles, said treating half of the planned number of participants for the ExBRT study is a milestone for determining this emerging treatment’s long-term clinical value in a standardized protocol for patients with early-stage breast cancer. “Enrollment to date is encouraging as treatment centers continue to provide appropriate patients with the option to complete a full dose of radiation therapy in a single treatment”, she added in the press release.
