FDA considers national breast cancer ablation registry

May 30, 2008

A national registry for thermal ablation treatment for breast cancer is under consideration by the FDA. The agency opened a six-month public comment period this week on the proposed registry, which would compile information on all thermal ablation devices and therapies for small carcinomas.

A national registry for thermal ablation treatment for breast cancer is under consideration by the FDA. The agency opened a six-month public comment period this week on the proposed registry, which would compile information on all thermal ablation devices and therapies for small carcinomas. The FDA is looking to determine if a registry could be used to standardize trials for different thermal ablation devices, such as focused ultrasound, cryoablation, and radiofrequency ablation. The registry would also lay out standard protocols for tumor selection, biopsy techniques, pathology studies, image guidance, and postablation assessment."Unfortunately, the lack of uniformity among different feasibility study protocols has resulted in various study results that cannot be easily compared," said an announcement in the May 28 Federal Registry. "The purpose of this critical path effort is to motivate the breast cancer ablation industry to standardize its feasibility study protocols so that data emerging are comparable in all respects."Comments must be submitted either through an electronic form or by mail. Comments will not be accepted by e-mail, the FDA announcement said.Click here to submit comments online. Mailed comments should be sent to: Division of Dockets Management (HFA-305), FDA5630 Fishers Lane, Room 1061Rockville, MD 20852The public comment period will close on November 24, 2008.Click here to learn more about the proposed registry, which will be administered through the FDA's Center for Devices and Radiological Health.For more information from the Diagnostic Imaging archives:Focused ultrasound spells a year of fibroid pain reliefCryoablation proves its palliative power in soft tissue, bone tumors

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