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

Status unconfirmed · Phase 1/Phase 2

Conditions studied: Brain Neoplasms

In brief

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 subjects with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.

Key facts

Study ID

NCT00787982

Run by

Visualase, Inc.

People needed

20

Starts

2008-09-01

Expected to finish

2010-09-01

Last updated by the study team

2010-01-01

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).
• 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.

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 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.

Where it is running

• North Shore University Hospital — Manhasset, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.