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Comments Sought on Breast Cancer Ablation Trials

05/28/2008

Federal Register Notice: FDA is seeking comments on whether a registry could facilitate standardization of feasibility trials studying local treatment of small breast cancers with different thermal ablation devices and therapies (i.e. cryoablation, focused ultrasound, interstitial laser, microwave, radiofrequency ablation). The agency is interested in understanding how such trials can be constructed so that there exists standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens. Comments should be submitted by 11/24. To view this notice, click here.

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