Magnetic Resonance Temperature Imaging & Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Stopped early · Not applicable

Conditions studied: Brain Tumor

In brief

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 magnetic resonance thermal imaging \[MRTI\]). The Visualase® Thermal Therapy System is used to treat metastatic brain tumors. Researchers want to find out if it is possible to use this new device in patients with metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.

Key facts

Study ID

NCT00720837

Run by

M.D. Anderson Cancer Center

People needed

6

Starts

2008-07-01

Last updated by the study team

2012-10-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UT MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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