The FDA is considering a national registry for thermal ablation treatment of breast cancer. The proposed registry would compile information on all thermal ablation devices and therapies for small carcinomas and address inconsistencies that potentially diminish the value of previously published feasibility protocols. It would also lay out standard protocols for tumor selection, biopsy techniques, pathology studies, image guidance, and postablation assessment.
The FDA described its rationale for a registry in the May 28 Federal Register. It will accept comments on the plan until Nov. 28.
