2008 U.S. Food and Drug Administration Critical Path Workshop - Clinical trials for local treatment of breast cancer by thermal ablation

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8:00 a.m.	Registration and Continental Breakfast

	Opening Remarks

9:00 a.m.	Welcome and Introductory Remarks Mark Barnett, M.P.H. Assistant Director for Education & Communication FDA Center for Devices and Radiological Health

9:05 a.m.	Keynote Address: FDA's Role in Medical Device Innovation Donna-Bea Tillman, Ph.D. Director, Office of Device Evaluation FDA Center for Devices and Radiological Health

9:20 a.m.	Introduction to the Workshop Binita Ashar, M.D., MBA, FACS Office of Device Evaluation U.S. FDA Center for Devices and Radiological Health

	*Examples of Feasibility Study Protocols*

9:35 a.m.	Perspectives of NCI's Image-Guided Interventions Branch Keyvan Farahani, Ph.D. Chief, Image-Guided Interventions Branch National Cancer Institute

9:45 a.m.	Perspectives of NCI's Cancer Therapy Evaluation Program Ted Trimble, M.D., M.P.H. Associate Chief, Surgery, Clinical Investigations Branch National Cancer Institute

9:55 a.m.	Cryoablation Rache Simmons, M.D.

10:00 a.m.	High Intensity Focused Ultrasound Mitchell Schnall, M.D., Ph.D.

10:10 a.m.	Interstitial Laser Kambiz Dowlat, M.D.

10:20 a.m.	Radiofrequency Ablation Suzanne Klimberg, M.D.

10:30 a.m.	Microwave Ablation Alan Fenn, Ph.D.

10:40 a.m.—11:00 a.m.	Audience Remarks

11:00 a.m.—11:15 a.m.	Break

	Challenge 1: How can potential investigators of thermal ablation technologies standardize their feasibility studies with respect to patient selection and technical device application? Invited Discussants: Rache Simmons, M.D. Mitch Schnall, M.D. Kambiz Dowlat, M.D. Suzanne Klimberg, M.D. Alan Fenn, Ph.D. Ismail Jatoi, M.D. Thomas Julian, M.D. Moderators: Mark Barnett, M.P.H. and Binita Ashar, M.D.

11:15 a.m.—11:45 a.m.	Moderated Discussion Regarding Standardization of Patient Selection Criteria

11:45 a.m.—noon	Audience Remarks

Noon—12:30 p.m.	Moderated Discussion Regarding Standardization of Device Application Protocols

12:30 p.m.—12:45 p.m.	Audience Remarks

12:45 p.m.—1:30 p.m.	Lunch—In Atrium

	Challenge 2: *How can we standardize feasibility study protocols in order to validate imaging findings with pathology results?* Invited Discussants: Kenneth Bloom, M.D. Peter Littrup, M.D. George Holland, M.D. Fraser Symmans, M.D. Fattaneh Tavassoli, M.D. Lakshmi Vishnuvajjala, Ph.D. Moderators: Mark Barnett, M.P.H and Binita Ashar, M.D., MBA

1:30 p.m.—1:40 p.m.	*Considerations When Validating a Biomarker* Lakshmi Vishnuvajjala, Ph.D.

1:40 p.m.—1:50 p.m.	*Overview of Ablated Breast Tumor Pathology* Kenneth Bloom, M.D.

1:50 p.m.—2:20 p.m.	Moderated Discussion Regarding Standardization of Imaging Assessments

2:20 p.m.—2:35 p.m.	Audience Remarks

2:35 p.m.—3:05 p.m.	Moderated Discussion Regarding Standardization of Pathology Protocols

3:05 p.m.—3:20 p.m.	Audience Remarks

3:20 p.m.—3:30 p.m.	Break

	Challenge 3: Depending on patient and tumor characteristics, the treatment care path for breast cancer potentially involves preoperative chemotherapy, operative resection with lymph node biopsy, radiation therapy and/or postoperative chemotherapy. How can we ensure that the addition of thermal ablation to the treatment care path will not compromise the effectiveness of the other modalities? Invited Discussants: Charles Geyer, M.D. Eduardo Moros, Ph.D. Joseph Sparano, M.D. Timothy Whelan, M.D. Julia White, M.D. Moderators: Mark Barnett, M.P.H.. and Richard Pazdur, M.D.

3:30 p.m.—4:00 p.m.	Moderated Discussion Regarding the Timing of Ablation With Respect to Lymph Node Biopsy, Chemotherapy, and Radiation Therapy

4:00 p.m.—4:15 p.m.	Audience Remarks

4:15 p.m.—4:45 p.m.	Moderated Discussion Regarding the Standardization of Chemotherapy and Radiation Therapy Protocols for Feasibility Studies

4:45 p.m.—5:00 p.m.	Audience Remarks

5:00 p.m.—5:10 p.m.	How a Patient Registry May Help to Implement a Standardized Framework for Feasibility Trials: Comments Received by FDA Long Chen, Ph.D. Office of Device Evaluation U.S. FDA Center for Devices and Radiological Health

5:00 p.m.—5:10 p.m.	Workshop Closing Remarks Binita Ashar, M.D., M.B.A. Office of Device Evaluation U.S. FDA Center for Devices and Radiological Health

	*Adjourn*

Sponsored by the FDA: September 15, 2008 | FDA White Oak Campus | Building 21 | 10903 New Hampshire Avenue | Silver Spring, MD 20993