Status:
TERMINATED
Magnetic Resonance Temperature Imaging & Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
BioTex, Inc.
Conditions:
Brain Tumor
Eligibility:
All Genders
Phase:
NA
Brief Summary
The goal of this clinical research study is to learn about a new therapy device called the Visualase® Thermal Therapy System (a device that uses a laser to kill tumor cells and is guided using magneti...
Detailed Description
The Study Device and Process: The Visualase® Thermal Therapy System combines 3 FDA-approved devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) beams to the tumo...
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). Failure is defined as local recurrence or failure of the previously treated lesion and will be determined by the treating surgeon based on a review of patient history and imaging.
- 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 BrainSUITE® 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) done on the day of treatment: -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 or the posterior fossa. -Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves. -Evidence of recent (\<2 weeks) hemorrhage.
- 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 received corticosteroids.
- Positive pregnancy test for women of child-bearing age.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00720837
Start Date
July 1 2008
Last Update
October 11 2012
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030