Mayo Clinic Study Leads to Food and Drug Administration Approval of Radio-Frequency Ablation for Treatment of Cancer Pain in Bone

Monday, October 21, 2002

What: An international clinical study led by Mayo Clinic in Rochester, Minn., showed that radio-frequency (RF) ablation significantly reduces pain and enhances quality of life for patients whose cancer has spread to the bone. The study provided evidence used by the U.S. Food and Drug Administration (FDA) to approve RF ablation for treatment of pain in cancer patients with two or three painful bone metastatic sites. The announcement of FDA approval was made today (Oct. 21, 2002).

RF ablation has been used for several years to treat liver and kidney cancer. The Mayo Clinic study shows that RF ablation can be equally effective in killing cancer cells that cause pain in the bone.

In addition to Mayo Clinic, the study was conducted at nine other medical centers in the United States, Italy, Germany and France. RITA Medical Systems, Inc., of Mountain View, Calif., developed the RF ablation technology that was used in the study and also provided partial funding for the research effort.

Who: The Mayo Clinic team of physicians involved in the recent study on which the FDA based its approval included William Charboneau, M.D., and Matthew Callstrom, M.D., Ph.D., radiologists; and Joseph Rubin, M.D., and Matthew Goetz, M.D., medical oncologists.

Patients: Interviews available with patients in Kansas City, Mo., Denver, Colo., and Billings, Mont.

Videotape: B-roll about the procedure and sound bites from physicians and a patient are available upon request.

Background: The Mayo Clinic study about RF ablation was presented at the 2002 annual meeting of the American Society of Clinical Oncology and published in a recent issue of the journal Radiology. The study showed that 95 percent of the 43 patients with incurable cancer who were treated with the RF ablation procedure experienced significant pain relief and had improved quality of life.

All of the study participants had previously received other standard treatments for pain but achieved minimal relief. Before RF ablation treatment, the pain these patients experienced averaged 7.5 on a scale of one to 10, with 10 being the worst level of unbearable pain. The pain was reduced an average of 50 percent eight weeks after the procedure and to an average score of one at 24 weeks following the procedure. Researchers continue to follow-up patients and have found that many of the surviving patients continue to have reduced pain one year after the initial RF ablation procedure. The RF ablation procedure takes about 30 to 60 minutes to perform. The patient is given a light general anesthetic, and a thin needle is inserted through the skin and guided by computed tomography or ultrasound imaging to the target area. An intense heat is transmitted through the tip of the needle, killing the nerve endings and much of the cancer tissue, thereby alleviating the pain.
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Mary Lawson
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e-mail: newsbureau@mayo.edu

John Murphy
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e-mail: newsbureau@mayo.edu

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