MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
Bone is the third most common organ involved by metastasic disease behind lung and liver. In
breast cancer, bone is the second most common site of metastatic spread, and 90% of patients
dying of breast cancer have bone metastasis. Breast and prostate cancer metastasize to bone
most frequently, which reflects the high incidence of both these tumors, as well as their
prolonged clinical courses.
Post cancer survival has increased with improvement in early detection and treatments. As
a consequence, the number of patients developing metastatic bone disease during their
lifetime has also increased. Patients with bone metastasis from breast cancer have an
average 2-year survival from the time of presentation with their first bone lesion. In
patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up
to 85% have evidence of bone metastases at the time of death.
Current treatments for patients with bone metastases are primarily palliative and include
localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal
therapy, radiopharmaceutical, and bisphosphanates), and analgesics (opioids and
non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested
as a treatment option for bone metastases. The main goals of these treatments are
improvement of quality of life and functional level. These goals can be further described:
1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4)
The study hypothesis is that MRgFUS is a safe and potentially effective non-invasive
treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the
result of this study the Sponsor will initiate a larger study in an effort to approve
metastatic bone tumors as an indication for its MRgFUS ExAblate device.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine safety of MRgFUS of Bone Metastases
Within 1 month of Treatment
Christine Chung, M.D.
University of California, San Diego
United States: Food and Drug Administration
|University of California at San Diego||La Jolla, California 92093|