A clinical study of the Safety and effectiveness of Magnetic Resonance-guided Focused Ultrasound Surgery (MRgFUS) treatment for the palliation of painful bone metastases

Not Applicable

• Conditions: metastatic bone tumor

• Registration Number: JPRN-UMIN000012441
• Lead Sponsor: Department of Orthopaedic Surgery, Kochi Medical School, Kochi University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-29
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

1. Patients who either -Need surgical stabilization of the affected bony structure, OR -Targeted tumor is at an impending fracture site, 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. Patients on dialysis 4. Patients with life expectancy < 3-Months 5. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study 6. 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 7. Patients with severe hypertension (diastolic BP > 100 on medication) 8. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight >113kilograms), etc. 9. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease 10. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 11. Karnofsky Performance Status (KPS) Score < 60 12. Severe cerebrovascular disease (multiple CVA or CVA within 6 months) 13. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.) 14. Are participating or have participated in another clinical trial in the last 30 days 15. Patients unable to communicate with the investigator and staff 16. Patients with persistent undistinguishable pain (pain source unidentifiable) 17. Patients who are pregnant or lactating 18. Patients with severe coagulation abnormalities 19. Any patients disqualified by a study physician because of medical, psychological or any other reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified