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)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov