FDA wants to know whether a registry could help standardize feasibility trials for local treatment of small breast cancers with different ablation devices and therapies, according to a Federal Register notice. FDA particularly wants to understand how such trials can be designed to provide standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, postablation imaging and assessment, and tissue pathology of ablated specimens. In 2003, the notice says, FDA's General and Plastic Surgery Devices Advisory Panel discussed issues pertaining to the use of thermal ablation devices to noninvasively treat breast cancer. The panel also discussed clinical trial issues pertaining to local treatment of breast cancer using thermal ablation versus operative resection. FDA says the panel's discussion has significantly affected regulation of the technologies. And investigators studying feasibility of thermal ablation devices for treating breast cancers have refined their techniques to the point that there have been small studies demonstrating nearly 100% ablation accuracy. However, FDA says, a lack of uniformity among different feasibility study protocols has resulted in study results that can' t be easily compared. --James G. Dickinson