ExAblate (MRgFUS) Treatment of Metastatic Bone Tumors for the Palliation of Pain
Trial ID or NCT#
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple Myeloma Tumors for the Palliation of Pain in Patients Who are not Candidates for Radiation Therapy
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic and Multiple Myeloma Bone Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation Therapy
- 1. Patients who either - Need surgical stabilization of the affected bony structure (>7 fracture risk score, see Section 7.3) OR - Targeted tumor is at an impending fracture site (>7 on fracture risk score, see Section 7.3). OR - Patients with surgical stabilization of tumor site with metallic hardware 2. More than 5 painful lesions, or more than 1 requiring immediate localized treatment 3. Targeted (treated) tumor is in the skull 4. Patients on dialysis 5. Patients with life expectancy < 3-Months 6. patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study. 7. Patients with unstable cardiac status including: - Unstable angina pectoris on medication - Patients with documented myocardial infarction within six months of protocol entry - Congestive heart failure requiring medication (other than diuretic) - Patients on anti-arrhythmic drugs 8. Severe hypertension (diastolic BP > 100 on medication) 9. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >250 pounds), etc. 10. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. 11. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 12. KPS Score < 60 (See "Definitions" below) 13. Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 14. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.) 15. Target (treated) tumor is less then 1cm from nerve bundles, bowels or bladder. 16. Are participating or have participated in another clinical trial in the last 30 days 17. Patients initiating a new chemotherapy regime, or radiation (for the targeted most painful lesion) within the last 2 weeks 18. Patients unable to communicate with the investigator and staff. 19. Patients with persistent undistinguishable pain (pain source unidentifiable) 20. Targeted (treated) tumor surface area >= 55 cm2 21. Patient whose bone-lesion interface is < 10-mm from the skin 22. Targeted (treated) tumor NOT visible by non-contrast MRI, 23. Targeted (most painful) tumor Not accessible to ExAblate 24. The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.
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