MR Guided Focused Ultrasound Surgery of Metastatic Bone Tumors
NCT ID: NCT00350233
Last Updated: 2012-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
10 participants
INTERVENTIONAL
2006-05-31
2010-02-28
Brief Summary
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Detailed Description
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Post cancer survival has increased with improvement in early detection and treatments. As a consequence, the number of patients developing metastatic bone disease during their lifetime has also increased. Patients with bone metastasis from breast cancer have an average 2-year survival from the time of presentation with their first bone lesion. In patients who die from breast, prostate, and lung cancer, autopsy studies have shown that up to 85% have evidence of bone metastases at the time of death.
Current treatments for patients with bone metastases are primarily palliative and include localized therapies (radiation and surgery), systemic therapies (chemotherapy, hormonal therapy, radiopharmaceutical, and bisphosphanates), and analgesics (opioids and non-steroidal anti-inflammatory drugs). Recently, radiofrequency ablation has been tested as a treatment option for bone metastases. The main goals of these treatments are improvement of quality of life and functional level. These goals can be further described: 1) Pain relief, 2) Preservation and restoration of function, 3) Local tumor control, 4) Skeletal stabilization.
The study hypothesis is that MRgFUS is a safe and potentially effective non-invasive treatment for metastatic bone tumors with a low incidence of co-morbidity. Based on the result of this study the Sponsor will initiate a larger study in an effort to approve metastatic bone tumors as an indication for its MRgFUS ExAblate device.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ExAblate MRgFUS
ExAblate 2000
Interventions
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ExAblate 2000
Eligibility Criteria
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Inclusion Criteria
2. Patients who are able and willing to give consent and able to attend all study visits
3. Patients with histologically or cytologically confirmed malignant disease with a bone lesion that appears to be metastatic disease by clinical and or imaging techniques
4. 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.
5. Targeted tumor(s) are ExAblate device accessible
6. Targeted tumor(s) size is smaller than 8 cm in diameter
7. Patient whose lesion is on bone and is ≥ 10-mm from the skin.
8. Tumor(s) clearly visible by non-contrast MRI
9. Able to communicate sensations during the MRgFUS ExAblate treatment
10. At least 2 weeks since chemotherapy
11. At least 1 month since radiation therapy
Exclusion Criteria
2. Patients who need pre-treatment surgical stabilization of the affected bony structure.
3. Targeted tumor is in weight bearing bones or impending fracture
4. Targeted tumor is in the vertebral column.
5. 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
6. Severe hypertension (diastolic BP \> 100 on medication)
7. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight \>250 pounds), etc.
8. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or Magnevist)
9. ASA Score\>2 (See "Definitions" below)
10. Extensive scarring in an area in the path of energy planned passage to the treatment area
11. Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
12. Patients on anti-coagulation therapy or those with an underlying bleeding disorder.
13. Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (approximately 3 hrs.)
14. Patient whose lesion is \< 10-mm from the skin
15. Patients with \< 2-Weeks since chemotherapy
16. Patient with \< 1-Month since radiation therapy
17. Patients with life expectancy \< 6-Months
18. Patients with surgical stabilization of tumor site with metallic hardware
18 Years
ALL
No
Sponsors
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InSightec
INDUSTRY
Responsible Party
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Principal Investigators
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Christine Chung, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
David Gianfelice, M.D.
Role: PRINCIPAL_INVESTIGATOR
Toronto General Hospital
Locations
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University of California at San Diego
La Jolla, California, United States
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Related Links
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Sponsor Web Page
Other Identifiers
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BM002
Identifier Type: -
Identifier Source: org_study_id