A Feasibility Study to Evaluate the Safety and Initial Effectiveness of ExAblate MR Guided Focused Ultrasound Surgery in the Treatment of Pain Resulting From Metastatic Bone Tumors With the ExAblate 2100 Conformal Bone System
The purpose of this study is to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- device : ExAblate 2100
Phase: Phase 1
Ages Eligible For Study:
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 4. One to 3 painful lesions. 5. Targeted tumor(s) 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. Patients with persistent distinguishable pain associated with up to 3 tumors of which a maximum of 2 tumors will be treated: o If patient has pain from additional sites that are not planned for treatment, 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(s) to be treated. 7. Patient with NRS (0-10 scale) pain score ? 4 at the targeted tumors (i.e: both tumors targeted for treatment must have NRS ? 4) irrespective of medication 8. Targeted tumors (most painful) size up to 8 cm in diameter 9. Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin. 10. Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible 11. Able to communicate sensations during the ExAblate MRgFUS treatment 12. At least 2 weeks since chemotherapy 13. No radiation therapy to targeted (most painful) tumors in the past two weeks