A post-market study has been launched to assess the safety and efficacy of iCAD’s FDA-cleared Xoft Axxent eVx System when used for single-fraction, intra-operative radiation therapy (IORT) at the time of lumpectomy for early stage breast cancer.
The prospective, multicenter trial will make an historical comparison to the current standard of external beam radiation therapy, according to Nashua, N.H.-based iCAD, which announced the study during the 29th annual Miami Breast Cancer conference.
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 studies also will assess cosmetic outcomes and quality of life for subjects treated with Xoft IORT.