Pilot study examines new radiofrequency ablation-assisted lumpectomy.

2004 DEC 2 - (NewsRx.com & NewsRx.net) -- The University of Arkansas for Medical Sciences (UAMS) and RITA Medical Systems, Inc. (Nasdaq:RITA) announced that the first patient in a planned series of 30 received a radiofrequency ablation-assisted lumpectomy procedure.

The procedure is intended to give the patient a cancer-free area around the site where the tumor has been removed so that repeat lumpectomies are unnecessary. The procedure may also offer similar protection against recurrence provided by the use of partial or whole breast radiation, the current standard of care following lumpectomy.

The clinical study, titled "Pilot study of radiofrequency ablation of breast cancer lumpectomy sites with indocyanine green confirmation to decrease re-operation," is designed to determine the benefits to the patient of using radiofrequency ablation (RFA) to ablate, or sear, a 1-cm margin or perimeter of soft tissue following standard lumpectomy removal of a breast tumor.

V. Suzanne Klimberg, MD, professor of Surgery and Pathology at UAMS and the Central Arkansas Veterans Healthcare Systems, chief of the Division of Breast Surgical Oncology at UAMS, and director of the Breast Cancer Program at UAMS' Arkansas Cancer Research Center, will treat up to 30 patients in the Phase I clinical trial.

The treatments will be performed under the guidelines of the investigational review board-approved pilot study with educational funding support provided in part by RITA Medical Systems of Mountain View, California. Additional support for the study will be provided by the Tenebaum Breast Cancer Research Program.

"Our goal is to change the way breast cancer is treated for the more than 100,000 women in the United States who undergo traditional lumpectomy for early stage breast cancer each year," Klimberg said. "Our initial research on donor mastectomy sections in the lab told us that RFA was effective in creating negative margins around small breast tumor. With the study we hope to prove that we can reduce the high re-operative rates associated with lumpectomy and offer added assurance that the cancer will not recur in these patients."

The researchers believe that giving patients a clear surgical margin at the time of the original lumpectomy will make unnecessary the estimated 40% of repeat lumpectomy procedures currently being done. The researchers also believe that the RFA-assisted lumpectomy procedure may offer similar protection against cancer recurring for some patients to the standard course of partial or whole-breast radiation therapy.