- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00787982
Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
Pilot Study Evaluating the Feasibility of Real-Time, Magnetic Resonance Thermal Imaging and Magnetic Resonance Imaging-Guided Laser Induced Thermal Therapy for Treatment of Metastatic Brain Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Visualase Thermal Therapy System is FDA-cleared for thermal destruction of soft tissue in neurosurgery under MRI guidance. The device combines 3 previously FDA-cleared devices: the Visualase Cooled Laser Application System, which delivers the laser (energy) to the tumor tissue; the PhoTex , Diode Laser Series, which is the laser itself; and the Visualase ENVISION Workstation, which is the computer system that helps the surgeon plan and monitor your treatment.
The Visualase Thermal Therapy System will be used in this study to give subjects a type of therapy called Laser Interstitial Thermal Therapy (LITT). LITT uses laser light to heat and destroy the affected tissue; this is sometimes referred to as tissue ablation. In LITT, small fiber-optic applicators are placed directly into the tumor and heating is performed from the inside out, which may lead to the destruction of the tumor. During the heating process, MRTI can be used to watch the temperatures around the applicator to make sure that the tumor receives enough treatment and that the normal tissues around the tumor do not get too hot.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Pamela Kribs, R.N., BSN
- Phone Number: 516-562-3058
- Email: pkribs@NSHS.edu
Study Locations
-
-
New York
-
Manhasset, New York, United States, 11030
- Recruiting
- North Shore University Hospital
-
Contact:
- pamela kribs, R.N.,BSN
- Phone Number: 516-562-3058
- Email: pkribs@NSHS.edu
-
Principal Investigator:
- Michael Schulder, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
- Three 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 >70 for patients over the age of 15.
- Lansky Play Scale >70 for patients 15 years of age or younger.
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, 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):
- 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.
- Lesions less than 5mm from primary branches of cerebral vessels, venous sinus, hypophysis or cranial nerves.
- Evidence of recent (<2 weeks) hemorrhage.
- Presence of more than 3 brain tumors at the time of enrollment.
- 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 receive corticosteroids.
- Positive pregnancy test for women of child-bearing age.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of technical success or failure to complete the initial procedure with no associated major complications.
Time Frame: within 24 hours following the procedure
|
within 24 hours following the procedure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Examination of the extent to which Visualase predictions based on MRTI data match lesion dimensions form post-therapy MRI assessments.
Time Frame: Immediately following treatment (day 0)
|
Immediately following treatment (day 0)
|
Estimates of durations, required facilities, required personnel, and costs for all aspects of the treatment procedure
Time Frame: from day 0 to patient release
|
from day 0 to patient release
|
Local control of treated lesions as defined by volume of lesions increasing by no more than 25%
Time Frame: Day 30, 90, and 180 days post procedure
|
Day 30, 90, and 180 days post procedure
|
Accrual of patient survival post Visualase therapy
Time Frame: Sooner of 3 years or patient death
|
Sooner of 3 years or patient death
|
Procedure-related morbidity and mortality
Time Frame: 30, 90,180 days post procedure
|
30, 90,180 days post procedure
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VIS-BR-08-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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