A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Trial ID or NCT#
Status
Purpose
The study hypotheses is that the proportion of patients experiencing clinically significant pain relief will be at least 30% greater than the proportion experiencing worsening pain.
Official Title
A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Eligibility Criteria
- - Men and women age 18 and older - Patients who are able and willing to give consent and able to attend all study visits - 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 - patients who refuse additional radiation therapy. - Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication - 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) - Targeted bone/tumor interface (most painful lesion) size up to 55 cm2 in surface area - Patient whose targeted (treated) lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin. - Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible - Able to communicate sensations during the ExAblate treatment - Patients on ongoing chemotherapy regimen at the time of eligibility: 1. with same chemotherapy regime (as documented from patient medical dossier), And 2. Worst pain NRS still ≥ 4 And 3. 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. - No radiation therapy to targeted (most painful) lesion in the past two weeks Bisphosphonate intake should remain stable throughout the study duration. - Patients will have from 1 to 5 painful lesions and only the most painful lesion will be treated. - 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).
- - Patients who either - Need surgical stabilization of the affected bony structure (>7 fracture risk score, see Section 7.4) OR - Targeted tumor is at an impending fracture site (>7 on fracture risk score, see Section 7.4). OR - Patients with surgical stabilization of tumor site with metallic hardware - More than 5 painful lesions, or more than 1 requiring immediate localized treatment - Targeted (treated) tumor is in the skull - Patients on dialysis - Patients with life expectancy < 3-Months - Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study. - 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 - Severe hypertension (diastolic BP > 100 on medication) - Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. - Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. - Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease - KPS Score < 60 (See "Definitions" below) - Severe cerebrovascular disease (multiple CVA or CVA within 6 months) - Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.) - Target (treated) tumor is less then 1cm from nerve bundles, bowels or bladder. - Are participating or have participated in another clinical trial in the last 30 days - 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. - Patients unable to communicate with the investigator and staff. - Patients with persistent undistinguishable pain (pain source unidentifiable of the targeted lesion) - Patient whose bone-lesion interface is < 10-mm from the skin - Targeted (most painful) tumor NOT visible by non-contrast MRI, - Targeted (most painful) tumor Not accessible to ExAblate - The targeted tumor is less than 2 points more painful compared to other painful lesions on the site specific NRS.
Investigator(s)
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Contact
CCTO
650-498-7061
View on ClinicalTrials.gov