Status:
TERMINATED
ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain
Lead Sponsor:
InSightec
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A study to evaluate the safety and initial effectiveness of the ExAblate 2100 Conformal Bone System in the treatment of pain resulting from metastatic bone tumors.
Detailed Description
Bone is the third most common organ involved by metastatic disease behind lung and liver \[6\]. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of...
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
- One to 3 painful lesions.
- 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)
- 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.
- 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
- Targeted tumors (most painful) size up to 8 cm in diameter
- Patient whose targeted (most painful) tumors are on bone and bone-lesion interface is deeper than 1cm from the skin.
- Targeted (most painful) tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible
- Able to communicate sensations during the ExAblate MRgFUS treatment
- At least 2 weeks since chemotherapy
- No radiation therapy to targeted (most painful) tumors in the past two weeks
Exclusion
- Patients who either
- Need surgical stabilization of the affected weight bearing bony structure (\>7 fracture risk score, see Section 6.9) OR
- Targeted tumor is at an impending fracture site of the weigh bearing bone (\>7 on fracture risk score, see Section 6.9).
- OR
- o Patients with surgical stabilization of tumor site with metallic hardware
- More than 3 painful lesions or more than 2 requiring immediate localized treatment
- The targeted tumor(s) is (are) less than 2 points more painful compared to other non-targeted painful lesions on the site specific NRS.
- Targeted tumor is in the skull
- Patients on dialysis
- Patients with life expectancy \< 6-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 (can be up to 4 hrs of total table time.)
- Target (most painful) tumor-bone interface is less then 1cm from nerve bundles, bowels or bladder.
- Are participating or have participated in another clinical trial for the palliation of their targeted bone metastasis tumors in the last 30 days
- Patients receiving chemotherapy or radiation (i.e., to the targeted lesion (s)) within the last two weeks
- Patients unable to communicate with the investigator and staff.
- Patients with persistent undistinguishable pain (pain source unidentifiable)
- Targeted (most painful) tumors size \> 8 cm in diameter
- Targeted (most painful) tumors:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 14 2016
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00981578
Start Date
September 1 2009
End Date
November 14 2016
Last Update
March 11 2020
Active Locations (5)
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1
City of Hope
Duarte, California, United States, 91010
2
University of California San Francisco
San Francisco, California, United States, 94107
3
Stanford University Medical Center
Stanford, California, United States, 94305
4
Methodist Hospital Research Institute
Houston, Texas, United States, 77030