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Using Functional MRI and Diffusion Tensor Imaging of the Motor and Language Pathways to Optimize Brain Tumor Resection


N/A
18 Years
N/A
Open (Enrolling)
Both
Brain Cancer

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Trial Information

Using Functional MRI and Diffusion Tensor Imaging of the Motor and Language Pathways to Optimize Brain Tumor Resection


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

standard vs. probabilistic tractography

Outcome 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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Robert Young, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-008

NCT ID:

NCT01534104

Start Date:

February 2012

Completion Date:

February 2014

Related Keywords:

  • Brain Cancer
  • fMRI
  • DTI
  • DSI
  • tractography
  • neurological/physical testing
  • Motor and Language Pathways
  • 12-008
  • Brain Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021