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Magnetic Resonance Temperature Imaging & Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
This study is currently recruiting participants.
Verified by M.D. Anderson Cancer Center, May 2009
First Received: July 21, 2008   Last Updated: May 11, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: 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

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

Resource links provided by NLM:


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 ]

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:

  1. Patient or family able and willing to give informed consent.
  2. 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.
  3. Tumor size </= 3.0 cm in largest diameter.
  4. MR imaging is not contraindicated for the patient
  5. Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
  6. Able and willing to attend all study visits.
  7. Karnofsky Performance Scale score >/=70 for patients over the age of 15.
  8. Lansky Play Scale>/=70 for patients 15 years of age or younger.

Exclusion Criteria:

  1. Patients or family unwilling or unable to give written consent.
  2. Patients who cannot physically fit in, or are too heavy for, the BrainSUITE® MRI scanner
  3. 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
  4. Known sensitivity to gadolinium-DTPA
  5. 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.
  6. Symptoms and signs of increased intracranial pressure
  7. Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
  8. Patients who are unable to received corticosteroids.
  9. 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

Additional Information:
No publications provided

Responsible Party: U.T. M.D. Anderson Cancer Center ( Jeffrey Weinberg, MD / Associate Professor )
Study ID Numbers: 2007-0610
Study First Received: July 21, 2008
Last Updated: May 11, 2009
ClinicalTrials.gov Identifier: NCT00720837     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Brain Tumor
Brain Cancer
MR-guided laser thermal ablation of brain tumors
Visualase® Thermal Therapy System
Magnetic Resonance Thermal Imaging
MRTI
Visualase Cooled Laser Application System
Laser Interstitial Thermal Therapy
LITT

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 November 09, 2009