In the study, microwave radiation focused externally on the breast will be delivered prior to lumpectomy and radiation therapy. The goal is to kill tumor cells and reduce additional surgery.
Early results from a prior phase II clinical trial were promising. A majority of the patients treated with the microwave heat therapy showed significant tumor kill prior to lumpectomy, according to Dr. Robert A. Gardner, a breast surgeon at Columbia Hospital's Center for Breast Care in West Palm Beach, Fla. (see MIT Tech Talk May 8, 2002).
Gardner and Dr. Hernan I. Vargas of Harbor-UCLA Medical Center presented the results at the 2002 American Society of Breast Surgeons Meeting in April and in the May 2002 issue of the Annals of Surgical Oncology. The data for 20 patients treated in that trial were submitted to the U.S. Food and Drug Administration, which resulted in FDA approval to proceed to the randomized final phase of clinical testing.
The women in the randomized clinical trials will be treated at Columbia Hospital, the University of Oklahoma (OU), Harbor-UCLA Medical Center, Martin Luther University in Halle, Germany and the Comprehensive Breast Center in Coral Springs, Fla. Additional sites have applied for Institutional Review Board Approval. The final phase of randomized clinical testing is expected to be completed by February 2004.
The technology itself was invented by Dr. Alan J. Fenn, a senior staff member at MIT Lincoln Laboratory. Fenn realized that the same focused microwave technology he'd used for missile detection could, in theory, be used to treat cancer cells.
Celsion Corporation exclusively licenses the focused microwave thermotherapy technology from MIT. The company has developed the clinical thermotherapy system and is funding the current clinical studies. The Department of the Air Force funded the original MIT Lincoln Laboratory research by Fenn.
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