Status:
UNKNOWN
Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
Lead Sponsor:
Visualase, Inc.
Conditions:
Brain Neoplasms
Eligibility:
All Genders
Phase:
PHASE1
PHASE2
Brief Summary
In this study, the Visualase Thermal Therapy System will be used on metastatic brain tumors that cannot be removed by surgery. Researchers want to find out if it is possible to use this new device in ...
Detailed Description
The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices: the Visualase Coole...
Eligibility Criteria
Inclusion
- Patient or family able and willing to give informed consent.
- Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radiosurgery, and/or whole brain radiotherapy).
- Three or fewer previously treated or untreated lesion(s) in the brain.
- Tumor size ≤ 3.0 cm in largest diameter.
- MR imaging is not contraindicated for the patient.
- Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
- Able and willing to attend all study visits.
- Karnofsky Performance Scale score \>70 for patients over the age of 15.
- Lansky Play Scale \>70 for patients 15 years of age or younger.
Exclusion
- Patients or family unwilling or unable to give written consent.
- Patients who cannot physically fit in, or are too heavy for, the MRI scanner.
- Patients with contra-indications to MRI imaging, such as, but not limited to, pacemakers or defibrillators, non-compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.
- Known sensitivity to gadolinium-DTPA.
- Based on Treatment Planning Imaging (MR and/or CT):
- Brain edema and/or mass effect that causes midline shift or shift in wall of ventricle of more than 5 mm.
- Lesions localized in the brain stem.
- Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
- Evidence of recent (\<2 weeks) hemorrhage.
- Presence of more than 3 brain tumors at the time of enrollment.
- Symptoms and signs of increased intracranial pressure.
- Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
- Patients who are unable to receive corticosteroids.
- Positive pregnancy test for women of child-bearing age.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00787982
Start Date
September 1 2008
End Date
September 1 2010
Last Update
January 1 2010
Active Locations (1)
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1
North Shore University Hospital
Manhasset, New York, United States, 11030