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

Sponsored by:	Visualase, Inc.
Information provided by:	Visualase, Inc.
ClinicalTrials.gov Identifier:	NCT00787982

Purpose

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.

Condition	Intervention	Phase
Brain Neoplasms	Device: MRI-Guided Laser Induced Thermal Therapy	Phase I Phase II

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Further study details as provided by Visualase, Inc.:

Primary Outcome Measures:

Rate of technical success or failure to complete the initial procedure with no associated major complications. [ Time Frame: within 24 hours following the procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Examination of the extent to which Visualase predictions based on MRTI data match lesion dimensions form post-therapy MRI assessments. [ Time Frame: Immediately following treatment (day 0) ] [ Designated as safety issue: No ]
Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure [ Time Frame: from day 0 to patient release ] [ Designated as safety issue: No ]
Local control of treated lesions as defined by volume of lesions increasing by no more than 25% [ Time Frame: Day 30, 90, and 180 days post procedure ] [ Designated as safety issue: No ]
Accrual of patient survival post Visualase therapy [ Time Frame: Sooner of 3 years or patient death ] [ Designated as safety issue: No ]
Procedure-related morbidity and mortality [ Time Frame: 30, 90,180 days post procedure ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787982

Contacts

Contact: Pamela Kribs, R.N., BSN

516-562-3058

pkribs@NSHS.edu

Locations

United States, New York
North Shore University Hospital	Recruiting
Manhasset, New York, United States, 11030
Contact: pamela kribs, R.N.,BSN 516-562-3058 pkribs@NSHS.edu
Principal Investigator: Michael Schulder, MD

Sponsors and Collaborators

Visualase, Inc.

More Information

Additional Information:

Sponsors website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	North Shore LIJ Health System ( Michael Schulder, MD , Vice Chairman , Department of Neurosurgery )
Study ID Numbers:	VIS-BR-08-001
Study First Received:	October 29, 2008
Last Updated:	November 7, 2008
ClinicalTrials.gov Identifier:	NCT00787982 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Visualase, Inc.:

brain
metastasis
neoplasm
tumor

Patients with secondary brain neoplasms
laser therapy
laser interstitial thermal therapy

Study placed in the following topic categories:

Brain Neoplasms
Neoplasm Metastasis
Central Nervous System Diseases

Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009