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

NCT00720837 | Terminated

• 1 other identifier: 2007-0610
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility: Rate of technical success or failure to complete initial procedure with no associated major complications.

  Safety: 30, 90, 180 day procedure-related morbidity and mortality

Study Arms (1)

Laser Interstitial Thermal Therapy

EXPERIMENTAL

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

Interventions

Visualase® Thermal Therapy System PROCEDURE

An intraoperative biopsy and placement of applicator for laser treatment. Treatment will last between 5 and 10 minutes.

Also known as: Laser Interstitial Thermal Therapy (LITT)

Laser Interstitial Thermal Therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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). 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.
• 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.

You may not qualify if:

• 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) 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.
• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• BioTex, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jeffrey Weinberg, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2008
• First Posted: July 23, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (1)