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

Sponsors and Collaborators:	M.D. Anderson Cancer Center BioTex, Inc.
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00720837

Purpose

Investigate hypothesis that real-time, MR-guided laser induced thermal ablation of brain lesions under real-time thermal imaging guidance is both a feasible and safe minimally-invasive technique for local, highly conformal therapy of metastatic brain tumors.

Condition	Intervention
Brain Tumor	Procedure: Visualase® Thermal Therapy System

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study

Official Title:

Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging (MRTI) and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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]). [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The safety of the device will also be studied. [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
To find out if it is possible to use this new device in patients with 1-3 metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:

22

Study Start Date:

July 2008

Estimated Primary Completion Date:

July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Laser Interstitial Thermal Therapy (LITT)	Procedure: Visualase® Thermal Therapy System An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.

Show Detailed Description

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) and for whom, at time of enrollment, surgery to pre-existing (treated or untreated) or new brain lesions has not been advised by a physician that is not associated with this study. Failure will be determined by the treating surgeon based on a review of patient history and imaging.
Three or less 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 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):
- 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.
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 received corticosteroids.
Positive pregnancy test for women of child-bearing age.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720837

Contacts

Contact: Jeffrey Weinberg, MD

713-792-2400

Locations

United States, Texas
U.T. M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Jeffrey Weinberg, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

BioTex, Inc.

Investigators

Principal Investigator:

Jeffrey Weinberg, MD

U.T. M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:

U.T. M.D. Anderson Cancer Center ( Jeffrey Weinberg, MD / Associate Professor )

Study ID Numbers:

2007-0610

First Received:

July 21, 2008

Last Updated:

November 3, 2008

ClinicalTrials.gov Identifier:

NCT00720837

Health Authority:

United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Brain Tumor
Brain Cancer
Visualase® Thermal Therapy System
Magnetic Resonance Thermal Imaging

MRTI
Visualase Cooled Laser Application System
Laser Interstitial Thermal Therapy
LITT

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 09, 2009