Pain Clinical Trial
Official title:
Phase II Study to Evaluate the Safety and 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
Verified date | March 2016 |
Source | InSightec |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Interventional |
The goal of this prospective, non-randomized, single-arm, phase 2 study is to evaluate the safety and effectiveness of this treatment using this ExAblate conformal system in the treatment of pain resulting from metastatic bone tumors Up to Fifty (50) patients will be recruited in this feasibility study. The treated patients will be followed for 3-Months post their last treatment, patients with the standard contraindications to MRI examination, such as implanted metal devices (pacemakers, etc.), will be excluded.
Status | Completed |
Enrollment | 50 |
Est. completion date | March 2013 |
Est. primary completion date | March 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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. 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) 5. Patient with NRS (0-10 scale) pain score = 4 at the targeted tumors irrespective of medication. 6. Patient who's targeted tumors are on bone and bone-lesion interface is more than 1cm from the skin, major nerve or hollow viscera. 7. Targeted tumors clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible 8. Able to communicate sensations during the ExAblate MRgFUS treatment Exclusion Criteria: 1. Patients who either: - Need surgical stabilization of the affected weight bearing bony structure OR - Targeted tumor is at an impending fracture site of the weigh bearing bone. OR - Patients with surgical stabilization of tumor site with metallic hardware 2. Target tumors-bone interface is less then 1cm from nerve bundles, bowels, skin or bladder. 3. Targeted (most painful) tumors: - NOT visible by non-contrast MRI, OR - NOT accessible to ExAblate device 4. Targeted tumor is in the skull 5. Patients on dialysis 6. Patients with life expectancy < 6-Months 7. Patients with an acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study. 8. Subjects with Patients with unstable cardiac status including: - Unstable angina pectoris on medication - Patients with documented myocardial infarction less than 40 days prior to protocol enrolment - Subjects with Severe Congestive Heart Failure, NYHA class 4. - Patients on anti-arrhythmic drugs or with uncontrolled and/or untreated arrhythmia status 9. Severe cerebrovascular disease (CVA within last 6 months) 10. Severe hypertension (diastolic BP > 100 on medication) 11. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc. 12. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist) including advanced kidney disease 13. Patients with an active infection or severe hematological, neurological, or other uncontrolled disease. 14. KPS Score < 60 (See "Definitions" below) 15. Patients unable to communicate with the investigator and staff. 16. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 2 hrs.) 17. Are participating or have participated in another clinical trial for the palliation of their targeted bone metastasis tumors in the last 30 days 18. Patients receiving new chemotherapy regime or radiation to the targeted lesion (s) within the last two weeks 19. Patients with persistent undistinguishable pain (pain source unidentifiable) |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Sheba MC | Ramat Gan |
Lead Sponsor | Collaborator |
---|---|
InSightec |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Evaluate incidence and severity of adverse events associated with ExAblate MRgFUS ExAblate Conformal system used in the palliation of pain due to metastatic bone tumors | 3 months post treatment | Yes |
Secondary | Efficacy | Level of pain relief (measured by Pain Scale) | 3 months post treatment | No |
Secondary | Effectiveness | Decrease in analgesics/opiate | 3 months post treatment | No |
Secondary | Effectiveness | Improved quality of life (measured by questionnaire) | 3 months post treatment | No |
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