Brigham and Women's Hospital Enrolling Patients in Clinical Study to Test Non-Invasive, Radiation-Free Procedure to Relieve Pain from Bone Metastases
December 1st, 2008
2008 DEC 1 -- Doctors at Brigham and Women's Hospital (BWH) are enrolling patients in a clinical study to evaluate whether an investigational therapy that combines Magnetic Resonance Imaging (MRI) and focused ultrasound safely and effectively reduces the pain caused from cancerous tumors that have spread to the bones. These secondary tumors that originated in another organ are also known as "bone metastases."
"Bone metastases are the most common cause of pain for cancer patients," notes Mark Hurwitz, MD, principal investigator and radiation oncologist at BWH. "We strive to help late-stage cancer patients maintain their quality of life, however current pain relieving treatments have several limitations. Patients whose bone pain returns or persists after a round of palliative radiation have few remaining options because they're generally too weak to withstand invasive pain-relieving procedures. Magnetic resonance-focused ultrasound has the potential to provide these patients a new non-invasive, radiation-free palliative treatment."
Bone is the third most common tissue to which cancer spreads, after the lungs and liver. Almost all patients with metastatic prostate cancer have skeletal metastases. In breast cancer, bone is the second most common site of metastatic spread, affecting 90% of patients with progressive form of the disease. Approximately 30% to 40% of lung cancer patients will develop bone metastases, as well. Every year in Massachusetts 4,480 people are diagnosed with breast cancer, while 4,930 and 3,800 are diagnosed with prostate and lung cancer, respectively.
Most cancer patients suffer from pain; controlling it and managing its symptoms are important treatment goals.
To perform the procedure, the physician uses an open MRI machine to visualize the patient's anatomy and then aims focused ultrasound waves at the targeted tissue to thermally ablate, or destroy it. The MRI allows the physician to monitor and continuously adjust the treatment in real time. The patient is consciously sedated to alleviate pain and minimize motion. Due to the high acoustic absorption and low thermal conductivity of the bone cortex, it is possible to use a low level of energy and still achieve a localized heating effect while minimizing damage to adjacent tissue.
Numerous other sites in the U.S., Canada and Israel are also participating in the study. These include Brigham and Women's Hospital in Boston; the Fox Chase Cancer Center in Philadelphia; Houston Methodist in Houston, TX; Lahey Clinic in Burlington, MA; University Health Network in Toronto; Sheba Medical Center in Israel; Sightline Medical Center-Houston; the University of California, Los Angeles (UCLA); the University of California, San Diego (UCSD) Medical Center in San Diego, CA; and Weill Cornell Medical College in New York.
The U.S. Food and Drug Administration (FDA) approved magnetic resonance-guided focused ultrasound (MRgFUS) to treat women suffering from symptomatic uterine fibroids in 2004. This same technology has shown promising efficacy and safety results in pain palliation feasibility studies in patients with bone metastases and the researchers hope to confirm the those results though this larger investigational trial.
MRgFUS received the European CE Mark certification for pain palliation of bone metastases in June. In clinical studies, which supported the CE mark, the majority of patients reported pain relief within days of treatment.
For more information on the study, contact Louise Greenberg at 617-732-5441 or visit: http://clinicaltrials.gov/ct2/show/NCT00656305?term=insightec&rank=2 or http://www.mycancerpain.org/.
Keywords: Anatomy, Bone, Breast Cancer, Breast Carcinoma, Clinical Trial Research, FDA, Infectious Disease, Lung Cancer, Lung Neoplasms, Magnetic Resonance, Metastatic Prostate Cancer, Metastatic Prostate Carcinoma, Oncology, Palliative Radiation, Prostatic Neoplasms, Pulmonology, Quality of Life, Respiratory Infection, Therapy, Treatment, U.S. Food and Drug Administration, Women's Health, Brigham and Women's Hospital.
This article was prepared by Biotech Business Week editors from staff and other reports. Copyright 2008, Biotech Business Week via NewsRx.com.
