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MRI-Guided LITT for Treatment Metastatic Brain Tumors

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ClinicalTrials.gov Identifier: NCT01736722
Recruitment Status : Withdrawn (PI change and no enrollment ever, therefore no data available.)
First Posted : November 29, 2012
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
The Methodist Hospital System

Brief Summary:

The Methodist Hospital Neurological Institute is conducting a clinical trial for patients suffering from Metastatic brain tumors. The objective for this study is to evaluate the safety and feasibility of a MRI-guided laser thermal therapy during a real-time MRI guidance for the treatment of brain metastasis.

Patient will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. The tumor will then be heated by the laser and monitored by study physicians through the real-time MRI to see and control temperatures in the tissue. One in place, the thermal laser will then surgically remove the lesions. After the procedure, post treatment MR images will thenbe acquired for the determination of the effective treatment region.


Condition or disease Intervention/treatment Phase
Brain Tumor Device: Visualase® Not Applicable

Detailed Description:

This is a study for evaluating the feasibility and safety of MR-guided laser thermal ablation of treatment-resistant brain tumors using the Visualase® Thermal Therapy System (Manufactured by BioTex, Inc., Houston, TX). The Visualase system is FDA cleared for soft tissue ablation in a number of surgical specialties including Neurosurgery (see appendix for documentation). Patients with intracranial brain tumors measuring 3 cm or smaller in largest diameter that have failed any conventional therapy (surgery, stereotactic radiosurgery and/or whole brain radiotherapy) are eligible.

The target tissue containing the tumor will undergo MRI-guided laser induced thermal therapy. MR imaging is used to define the treatment volume as well as plan and verify placement of the applicator. The extent of ablation is quantitatively monitored and displayed during delivery using real-time, MR temperature imaging. MR temperature imaging will also be used to monitor and control the temperature of adjacent tissues. Treatment will be automatically stopped if the MR temperature feedback system reports the temperature in the adjacent tissue has risen above a preset threshold. Treatment can be manually stopped by the neurosurgeon monitoring the treatment in real-time at any point during the procedure by simply turning off the power to the laser from the Visualase® system console. After laser delivery, MR images can be used to verify the extent of treatment and plan a therapy delivery if necessary.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of MRI-Guided Laser Induced Thermal Therapy (LITT) for Metastatic Brain Tumors
Actual Study Start Date : January 22, 2009
Actual Primary Completion Date : March 5, 2014
Actual Study Completion Date : March 5, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: MRI-guided laser induced thermal therapy
The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.
Device: Visualase®
The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.




Primary Outcome Measures :
  1. Safety and Feasibility [ Time Frame: 30d ]
    Safety: To determine that the procedure can be safely tolerated without adverse events based on day 30 procedure-related morbidity and mortality. Feasibility: To determine that the the rate of technical success or failure to complete the initial procedure with no associated major complications.


Secondary Outcome Measures :
  1. Number of patients with survival [ Time Frame: 30 days ]

    30 day imaging evaluation of the laser induced lesion Correlation: examination of the extent to which Visulase predictions based on MRTI data match lesion dimensions from post-therapy MRI assessments. Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure. Local control of lesions at 30 day as defined by volume of lesion increasing by no more than 25%.

    Accrual of patient survival post Visualase therapy.




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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. High-grade gliomas, metastatic brain tumors, and other brain tumors refractory to conventional medical therapy.
  2. Patient or family able and willing to give informed consent.
  3. Subjects with metastatic cancer to the brain who have failed at least one conventional therapy (surgery, stereotactic radio- surgery, chemotherapy, and/or whole brain radiotherapy).
  4. Four or fewer previously treated or untreated lesion(s) in the brain.
  5. Tumor size ≤ 3.0 cm in largest diameter.
  6. MR imaging is not contraindicated for the patient.
  7. Lesion(s) are clearly defined on pre-therapy contrast enhanced MRI scans as determined by the treating surgeon.
  8. Able and willing to attend all study visits.
  9. Karnofsky Performance Scale score >50.
  10. Patients age 19 and older.

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 MRI scanner.
  3. Patients with contra-indications to MRI imaging, such as, but not limited to, some pacemakers or defibrillators, non- compatible aneurysm clips, shrapnel, or other internal ferromagnetic objects.
  4. Known sensitivity to gadolinium-DTPA, or glomerular filtration rate not compatible with receiving gadolinium-DTPA.
  5. Based on Treatment Planning Imaging (MR and/or CT):

    • Lesions localized in the brain stem.
    • Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
    • Presence of more than 4 brain tumors at the time of enrollment.
    • Medical issues which prohibit the patient from undergoing surgery (as determined by the treating surgeon, anesthesiologist, IMPAC clinic, referring physician).
    • Positive pregnancy test for women of child-bearing age.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736722


Locations
United States, Texas
Methodist Neurological Institute - Department of Neurosurgery
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: Pamela Z New, M.D. Methodist Neurological Institute

Additional Information:
Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01736722     History of Changes
Other Study ID Numbers: Pro00002569
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share data at this time.

Keywords provided by The Methodist Hospital System:
Laser Induced Thermal Therapy
Metastatic cancer
Brain Tumor
Visualase
Treatment resistant
Magnetic Resonance Thermal Imaging
Magnetic Imaging

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