MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning

Not Applicable

Completed

• Conditions: Brain Cancer
• Interventions: Procedure: preoperative fMRI. DTI and DSI with tractography

• Registration Number: NCT01534104
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-16
• Status Verified: 2023-06
• Primary Completion: 2023-06-08
• Study Completion: 2023-06-08
• Last Update Submitted: 2023-06-08
• Last Update Posted: 2023-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 145

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pts who have primary or secondary brain tumors	preoperative fMRI. DTI and DSI with tractography	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.

Primary Outcome Measures

Name	Time	Method
standard vs. probabilistic tractography	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.

Secondary Outcome Measures

Name	Time	Method
the utility of diffusion spectrum imaging (DSI)	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.
feasibility of updated fMRI sequences	2 years	(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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States