Status:
COMPLETED
MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
Lead Sponsor:
InSightec
Conditions:
Bone Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.
Detailed Description
Bone is the third most common organ involved by metastasic disease behind lung and liver. In breast cancer, bone is the second most common site of metastatic spread, and 90% of patients dying of breas...
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 with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
- Must have persistent pain from at least one site of bone metastases
- Patient with VAS pain score ≥ 4, when VAS test taken without medication, OR
- Patient taking pain-relieving medication for management of bone metastases.
- Targeted tumor(s) are ExAblate device accessible
- Targeted tumor(s) size is smaller than 8 cm in diameter
- Patient whose lesion is on bone and is ≥ 10-mm from the skin.
- Tumor(s) clearly visible by non-contrast MRI
- Able to communicate sensations during the MRgFUS ExAblate treatment
- At least 2 weeks since chemotherapy
- At least 1 month since radiation therapy
Exclusion
- Diffuse skeletal tumoral spread as evaluated by imaging.
- Patients who need pre-treatment surgical stabilization of the affected bony structure.
- Targeted tumor is in weight bearing bones or impending fracture
- Targeted tumor is in the vertebral column.
- 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 (weight \>250 pounds), etc.
- Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
- ASA Score\>2 (See "Definitions" below)
- Extensive scarring in an area in the path of energy planned passage to the treatment area
- Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
- Patients on anti-coagulation therapy or those with an underlying bleeding disorder.
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)
- Patient whose lesion is \< 10-mm from the skin
- Patients with \< 2-Weeks since chemotherapy
- Patient with \< 1-Month since radiation therapy
- Patients with life expectancy \< 6-Months
- Patients with surgical stabilization of tumor site with metallic hardware
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00350233
Start Date
May 1 2006
End Date
February 1 2010
Last Update
September 17 2012
Active Locations (2)
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1
University of California at San Diego
La Jolla, California, United States, 92037
2
Toronto General Hospital
Toronto, Ontario, Canada, MG5 2C4