FDA considers registry for breast cancer thermal ablation trials
The agency said it is specifically interested in understanding how breast cancer ablation feasibility trials can be constructed, while maintaining uniform evaluation methods 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.
According to the FDA, 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.”
Creating a registry could help develop best practices for imaging and pathologic assessment, the agency said. 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.