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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01534104
First received: February 9, 2012
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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. These patients usually get functional MRI (fMRI) and diffusion tensor imaging (DTI). These special MRI sequences are used to plan surgery. The researchers are studying the parts of the brain involved in motor and language. Patients are scheduled to have fMRI and DTI, and then undergo 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 fMRI and DTI scans are necessary stimulation for this protocol are part of the standard of care. In other words, these tests 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.

If the patient agrees we may also perform an optional diffusion spectrum imaging (DSI). This is a modified version of the usual DTI scan that we routinely acquire. DSI may help us better identify connections between different parts of the brain. The DSI is for research only. The patient would not get DSI if they choose not to enroll in this study.


Condition Intervention
Brain Cancer
Procedure: preoperative fMRI. DTI and DSI with tractography

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Using Functional MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • standard vs. probabilistic tractography [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 feasibility of diffusion spectrum imaging (DSI) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    (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.


Estimated Enrollment: 75
Study Start Date: February 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: preoperative fMRI. DTI and DSI with tractography
Within approximately 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 * Most patients will undergo surgery within 48 hrs of their preoperative MRI. However, for some patients, the MRI results will be used for preoperative counseling. In this subset of patients, we expect that surgery will occur within 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary or secondary brain tumor (enhancing mass lesion ± nonenhancing abnormality) 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 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:

  • Any contraindication to MRI (e.g., claustrophobia, pacemaker, aneurysm clip, tissue expander)
  • Unable to cooperate for MRI and/or perform fMRI tasks
  • Pregnant or nursing female
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01534104

Contacts
Contact: Robert Young, MD 212-639-8196
Contact: Andrei Holodny, MD 212-639-3182

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Robert Young, MD    212-639-8196      
Contact: Andrei Holodny, MD    212-639-3182      
Principal Investigator: Robert Young, MD         
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Robert Young, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01534104     History of Changes
Other Study ID Numbers: 12-008
Study First Received: February 9, 2012
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
fMRI
DTI
DSI
tractography
neurological/physical testing
Motor and Language Pathways
12-008

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014