- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01534104
MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
Using Functional MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
Many patients with brain tumors require surgery. Some patients have brain tumors near important parts of the brain. These brain areas have roles in language or motor function. Avoiding these motor and language areas helps to prevent neurological deficits. The investigators are studying the parts of the brain involved in motor and language. Patients usually get functional MRI (fMRI) or resting-state fMRI (rs-fMRI) for gray matter mapping and diffusion tensor imaging (DTI) or diffusion spectrum imaging (DSI) for white matter mapping. These special MRI sequences are used to plan surgery. Patients are scheduled to have imaging to help plan for possible surgery.
Some patients may require stimulation during surgery to motor and language areas. In patients who require stimulation as part of their standard of care, the investigators will compare the investigators imaging results with the stimulation results. The purpose of this study is to improve MRI mapping of the motor and language pathways in the brain.
The scans are necessary stimulation for this protocol are part of the standard of care. In other words, these tests are done as part of the best possible care even if they did not join this study. The investigators are studying new techniques for analyzing the MRI data. These new techniques may give the doctor a better view of where the brain tumor is located relative to important parts of the brain.
The investigators will only perform the test sequences that are necessary for mapping the tumor. Most patients will require both fMRI and DTI. Some patients may only require fMRI or DTI. The investigators may also ask to perform optional sequences during the scan. Multi-echo is an modified form of fMRI. DSI is a modified form of DTI. These optional sequences are for research only. The patient would not get these sequences if they do not enroll in this study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Primary or secondary brain tumor (enhancing mass lesion ± nonenhancing abnormality), known or suspected, located near (< 2 cm) any portion of the motor cortex, motor pathway, language cortex, or language pathway as determined on anatomical images;
- Planned resection of the tumor;
- fMRI and/or DTI required for preoperative imaging as part of the standard of care
- Patient and/or guardian is able to provide written informed consent prior to study registration
- Age ≥ 18 years old
Exclusion Criteria:
- Unable to tolerate MRI and/or perform fMRI tasks (e.g., severe claustrophobia or pacemaker or aneurysm clip that precludes MRI scan)
- Pregnant or nursing female
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pts who have primary or secondary brain tumors
The study will prospectively enroll subjects who have primary or secondary brain tumors located near the motor pathway (corticospinal tract) or language pathway (arcuate fasciculus).
This is a nonrandomized study in which each subject will receive the standard of care as per the treating neurosurgeon.
|
W/I approx 4-6 weeks of the fMRI, DTI & DSI, neurological/physical testing & brain MRI showing tumor &/or edema located in or near (<2 cm) the motor cortex (precentral gyrus), motor pathway (corticospinal tract), language cortex (Broca's area, Wernicke's area), &/or language pathway (arcuate fasciculus) Preoperative MRI for surgical planning (approximately <48 hours before surgery*) fMRI to localize gray matter DTI, DSI & tractography to localize white matter, DSI & updated fMRI (Optional) Most patients will undergo surgery w/i 48 hrs of their preoperative MRI.
For some patients, the MRI results will be used for preoperative counseling.
In this subset of patients, we expect that surgery will occur w/i 3-4 months of the MRI.
Brain tumor resection as per the treating neurosurgeon Electrical stimulation to localize gray &/or white matter structures if clinically necessary according to the standard of care at MSKCC Postoperative neurological/physical examination (<48 hours after surgery)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
standard vs. probabilistic tractography
Time Frame: 1 year
|
The standard and probabilistic tractography results will be compared to expected anatomy as determined by expert operators.
The reconstructed tracts will be examined for their configurations near the tumor and/or edema, and the completeness of their courses.
All analyses will be scored by two expert operators (2 board certified radiologists who hold Certificates of Added Qualification in Neuroradiology and are familiar with DTI and tractography), with disagreements resolved by consensus.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the utility of diffusion spectrum imaging (DSI)
Time Frame: 2 years
|
(Optional) DSI is a newly proposed modification of DTI that allows potentially improved visualization of the complex white matter architecture.
Recent technical advances have allowed marked reduction of the DSI scan time to match other clinical scan times.
DSI in brain tumor patients has not been described Analysis of the DSI results will be performed in a manner similar to the analysis for DTI in Specific Aim #1.
Briefly, the endings of the rostral language tracts will be graded as: 0-none; 1-few; 2-some; or 3-all for tracts extending to the fMRI activated Broca's area.
Both motor and language tracts will be compared to the contralateral mirror tract using a similar 0-3 scale (0-absent, 3-normal) by two expert operators with disagreements resolved by consensus.
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2 years
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feasibility of updated fMRI sequences
Time Frame: 2 years
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(Optional) rs-fMRI is a newly proposed technique to map functional networks in the brain with data obtained during a quiet, resting state condition - as opposed to the usual task-based fMRI that requires patient cooperation and performance.
This is an exploratory aim and no statistical analyses are expected to be performed.
We anticipate that all of the patients who undergo rs-fMRI will be able to lie still for the additional approximate 7 min required to acquire the updated fMRI sequence.
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Young, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
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
- 12-008
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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