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

NCT ID: NCT00787982

Last Updated: 2010-01-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2010-09-30

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

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 Cooled Laser Application System, which delivers the laser (energy) to the tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment.

The Visualase Thermal Therapy System will be used in this study to give subjects a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.

Conditions

Brain Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

MRI-Guided Laser Induced Thermal Therapy

LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Visualase, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

North Shore LIJ Health System

Locations

North Shore University Hospital

Manhasset, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela Kribs, R.N., BSN

Role: CONTACT

pkribs@NSHS.edu

516-562-3058

Facility Contacts

pamela kribs, R.N.,BSN

Role: primary

pkribs@NSHS.edu

516-562-3058

Related Links

http://www.visualaseinc.com

Sponsors website

Other Identifiers

VIS-BR-08-001

Identifier Type: -

Identifier Source: org_study_id