MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
Primary Purpose
Brain Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
preoperative fMRI. DTI and DSI with tractography
Sponsored by
About this trial
This is an interventional prevention trial for Brain Cancer focused on measuring fMRI, DTI, DSI, tractography, neurological/physical testing, Motor and Language Pathways, resting state fMRI, 12-008
Eligibility Criteria
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
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pts who have primary or secondary brain tumors
Arm Description
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.
Outcomes
Primary Outcome Measures
standard vs. probabilistic tractography
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.
Secondary Outcome Measures
the utility of diffusion spectrum imaging (DSI)
(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.
feasibility of updated fMRI sequences
(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.
Full Information
NCT ID
NCT01534104
First Posted
February 9, 2012
Last Updated
June 8, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT01534104
Brief Title
MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
Official Title
Using Functional MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
June 8, 2023 (Actual)
Study Completion Date
June 8, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer
Keywords
fMRI, DTI, DSI, tractography, neurological/physical testing, Motor and Language Pathways, resting state fMRI, 12-008
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pts who have primary or secondary brain tumors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
preoperative fMRI. DTI and DSI with tractography
Intervention Description
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)
Primary Outcome Measure Information:
Title
standard vs. probabilistic tractography
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
the utility of diffusion spectrum imaging (DSI)
Description
(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.
Time Frame
2 years
Title
feasibility of updated fMRI sequences
Description
(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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Young, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
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MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
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