MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors

Completed · Phase 1

Conditions studied: Bone Metastases

In brief

The objective of this trial is to evaluate the safety and effectiveness of MRgFUS in the treatment of metastatic bone tumors.

Key facts

Study ID

NCT00350233

Run by

InSightec

People needed

10

Starts

2006-05-01

Expected to finish

2010-02-01

Last updated by the study team

2012-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California at San Diego — La Jolla, California, United States
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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