A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain in Subjects who are Not Candidates for Radiation Therapy
Study Status
Open to Enrollment
Study Description
Treatment with external beam radiation therapy (EBRT) is the standard of care for patients with localized bone pain. Patients who had EBRT and failed to improve may need to seek other therapies. The ExAblate system may be meet the needs of patients who failed to improve with standard therapy.
Patients will metastatic cancer to the bone who have failed adequate pain control with other standard therapy will be treated with the ExAblate procedure and followed over a three-month post-therapy period to determine the safety and effectiveness of the ExAblate procedure for palliation of pain.
Patients will be randomized to one of the two study arms:
- Arm A: ExAblate procedure to the most painful target lesion
- Arm B: Placebo ExAblate treatment
Key Eligibility
- Men and women age 18 and older
- Suffering from symptoms of bone metasteses or multiple myeloma bone lesions
- Must have been treated with at least one standard therapy (systemic therapy or local irradiation therapy) and must have failed adequate pain control with such therapy
- Radiation failure candidates are those who have received radiation without adequate relief from metastatic bone pain as determined by the patient and referring physician, those for whom their treating physician would not presribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy
- Additional eligibility criteria discussed when you contact the study team
Principal Investigator
Contact
- Gina Mileo, RN
- (212) 746-5430
- [email protected]
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]
