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

This study has been terminated.
(Slow Accrual)
Sponsor:
Collaborator:
BioTex, Inc.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00720837
First received: July 21, 2008
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

The goal of this clinical research study is 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]). The Visualase® Thermal Therapy System is used to treat metastatic brain tumors. Researchers want to find out if it is possible to use this new device in patients with metastatic brain tumor(s), each measuring 3 centimeters (cm) or smaller. The safety of the device will also be studied.


Condition Intervention
Brain Tumor
Procedure: Visualase® Thermal Therapy System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:
  • Feasibility: Rate of technical success or failure to complete initial procedure with no associated major complications. [ Time Frame: Safety: 30, 90, 180 day procedure-related morbidity and mortality ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: July 2008
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser Interstitial Thermal Therapy
Laser Interstitial Thermal Therapy (LITT) - An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.
Procedure: Visualase® Thermal Therapy System
An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.
Other Name: Laser Interstitial Thermal Therapy (LITT)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
BioTex, Inc.
Investigators
Principal Investigator: Jeffrey Weinberg, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00720837     History of Changes
Other Study ID Numbers: 2007-0610
Study First Received: July 21, 2008
Last Updated: October 10, 2012
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
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 11, 2014