Skip to main content
Clinical Trials/NCT01534104
NCT01534104
Completed
Not Applicable

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

Memorial Sloan Kettering Cancer Center1 site in 1 country145 target enrollmentFebruary 2012
ConditionsBrain Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Cancer
Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
145
Locations
1
Primary Endpoint
standard vs. probabilistic tractography
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
June 8, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • the utility of diffusion spectrum imaging (DSI)(2 years)
  • feasibility of updated fMRI sequences(2 years)

Study Sites (1)

Loading locations...

Similar Trials