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MRI-Guided LITT for Treatment Metastatic Brain Tumors

Primary Purpose

Brain Tumor

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visualase®
Sponsored by
The Methodist Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumor focused on measuring Laser Induced Thermal Therapy, Metastatic cancer, Brain Tumor, Visualase, Treatment resistant, Magnetic Resonance Thermal Imaging, Magnetic Imaging

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Methodist Neurological Institute - Department of Neurosurgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI-guided laser induced thermal therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Safety and Feasibility
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

Number of patients with survival
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.

Full Information

First Posted
November 19, 2012
Last Updated
January 15, 2018
Sponsor
The Methodist Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01736722
Brief Title
MRI-Guided LITT for Treatment Metastatic Brain Tumors
Official Title
Use of MRI-Guided Laser Induced Thermal Therapy (LITT) for Metastatic Brain Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Withdrawn
Why Stopped
PI change and no enrollment ever, therefore no data available.
Study Start Date
January 22, 2009 (Actual)
Primary Completion Date
March 5, 2014 (Actual)
Study Completion Date
March 5, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Methodist Hospital Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumor
Keywords
Laser Induced Thermal Therapy, Metastatic cancer, Brain Tumor, Visualase, Treatment resistant, Magnetic Resonance Thermal Imaging, Magnetic Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI-guided laser induced thermal therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Visualase®
Intervention Description
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 Measure Information:
Title
Safety and Feasibility
Description
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.
Time Frame
30d
Secondary Outcome Measure Information:
Title
Number of patients with survival
Description
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.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: High-grade gliomas, metastatic brain tumors, and other brain tumors refractory to conventional medical therapy. 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 radio- surgery, chemotherapy, and/or whole brain radiotherapy). Four or fewer 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 >50. Patients age 19 and older. Exclusion Criteria: Patients or family unwilling or unable to give written consent. Patients who cannot physically fit in, or are too heavy for, the MRI scanner. 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. Known sensitivity to gadolinium-DTPA, or glomerular filtration rate not compatible with receiving gadolinium-DTPA. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Z New, M.D.
Organizational Affiliation
Methodist Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist Neurological Institute - Department of Neurosurgery
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data at this time.
Links:
URL
http://www.methodisthealth.com/ni.cfm?id=35605
Description
Related Info

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MRI-Guided LITT for Treatment Metastatic Brain Tumors

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