Background

Thermal ablation devices, which cause tissue necrosis through freezing or coagulation, are being studied as a local treatment for tumors. Feasibility studies of thermal ablation devices for the treatment of breast cancers, which generally consist of tumor ablation followed by resection with pathologic assessment, have used cryoablation, radiofrequency ablation, focused ultrasound, interstitial laser and microwave devices. Some investigators have reported nearly 100 percent ablation accuracy. However, the lack of uniformity among different feasibility study protocols has resulted in study results that cannot be easily compared. This makes it difficult to establish “best practices” for tumor ablation, e.g., a standard protocol for pathological assessment of an ablated breast cancer, or patient selection criteria for breast cancer ablation.

To resolve this problem, it would be helpful if investigators designing feasibility studies had a common framework that would include protocols for imaging, pathology, and treatment care path. Patient registries might also help implement this framework, and FDA is seeking public comment on the Potential for a Registry of Breast Cancer Treatment Using Thermal Ablation.

Workshop Format

Invited Discussants, who represent experts involved in the multispecialty care of patients with breast cancer, will discuss issues pertaining to feasibility studies of breast cancer thermal ablation. Each session will be followed by open discussions.

Workshop Participation

Participation in the Workshop will consist of both Invited Discussants and audience members. The Invited Discussants completed a work assignment in advance of the meeting in order to optimize the time spent during the workshop. Audience participation is open to all who are interested in clinical trials for local treatment of breast cancer by thermal ablation and will be scheduled throughout the sessions.