Painful Bone Metastases
Conditions
Interventions
Treatment:MRgFUS
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
25 Years to 86 Years
Inclusion criteria
Inclusion criteria: 1. Men and women age 18 and older; 2. Patients who are able and willing to give consent and able to attend all study visits; 3. Patients who are suffering from symptoms of bone metastases or multiple myeloma bone lesions: Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy; 4. Patient with NRS (0-10 scale) pain score >= 4 irrespective of medication; 5. Targeted bone/tumor interface are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3 – L5), Sacral vertebra (S1 – S5); 6. Targeted bone/tumor interface (most painful lesion) size up to 100 cm2 in surface area; 7. Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin; 8. Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible; 9. Able to communicate sensations during the ExAblate treatment; 10. Patients on ongoing chemotherapy regimen at the time of eligibility: with same chemotherapy regime (as documented from patient medical dossier), and worst pain NRS still >= 4 and do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy; 11. No radiation therapy to targeted (most painful) lesion in the past two weeks; 12. Bisphosphonate intake should remain stable throughout the study duration; 13. Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated; 14. Patients with persistent distinguishable pain associated with 1 site to be treated (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2 points on the NRS compared to the site to be treated).
Exclusion criteria
Exclusion criteria: 1. Patients who either Need surgical stabilization of the affected bony structure (>7 fracture risk score) or Targeted tumor is at an impending fracture site (>7 on fracture risk score), 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 100 on medication); 9. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, 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 for pain purposes only, or radiation (for the targeted most painful lesion) within the last 2 weeks.Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy; 18. Patients unable to communicate with the investigator and staff; 19. Patients with persistent undistinguishable pain (pain source unidentifiable of the targeted lesion); 20. Patient whose bone-lesion interface is < 10-mm from the skin; 21. Targeted (most painful) tumor NOT visible by non-contrast MRI; 22. Targeted (most painful) tumor Not accessible to ExAblate; 23. The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numerical Rating Scale (NRS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Brief Pain Inventory-Quality of Life (BPI-QoL) scale; | — |
Countries
China
Contacts
Public ContactHan wang
Shanghai General Hospital
Outcome results
None listed