Registry for Breast Cancer Thermal Ablation Trials Considered

The FDA is asking industry whether it makes sense to set up a registry for feasibility studies of local treatment of small breast cancers using different thermal ablation devices and therapies.

The registry could help design such studies with standardized protocols specifying uniform methods of evaluating tissue biopsy pathology, the selection of tumors amenable to ablation, image guidance for ablation, post-ablation imaging and assessment, and tissue pathology of ablated specimens.

The registry would collect information on studies involving cryoablation, focused ultrasound, interstitial laser, microwave and radio-frequency ablation. Small studies have demonstrated almost 100 percent ablation accuracy, but “unfortunately, the lack of uniformity among different feasibility study protocols has resulted in various study results that cannot be easily compared,” the agency says.

Creating a registry could help develop best practices for imaging and pathologic assessment. A registry also might help identify the conditions under which imaging would be a good surrogate for pathology and distinguish the genotypes of patients who respond well to therapy from those who do not, the FDA says.