Status:
COMPLETED
A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain
Lead Sponsor:
InSightec
Conditions:
Bone Metastasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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.
Detailed Description
As part of the PMA # P110039 review process and approval, InSightec was requested to conduct a post-approval study. Patients will be treated following the approved commercial treatment guidelines. Fo...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT01833806
Start Date
September 1 2013
End Date
January 14 2022
Last Update
April 7 2023
Active Locations (9)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California Los Angeles
Los Angeles, California, United States, 90024
3
University of California San Francisco
San Francisco, California, United States, 94107
4
Stanford University School of Medicine
Stanford, California, United States, 94305