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Presurgical Planning With Functional MRI (fMRI) Mapping of Motor Cortex in Patients With Cerebral Tumors

This study has been completed.
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by:
University of Michigan Identifier:
First received: July 25, 2008
Last updated: August 4, 2011
Last verified: August 2011
The purpose of this study is to determine if functional MRI is precise enough to be used in preoperative decision making for patients who have brain tumors.

Condition Intervention Phase
Brain Tumors
Procedure: Presurgical MRI
Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors

Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Determining whether fMRI mapping is as effective as invasive presurgical mapping. [ Time Frame: Time of procedure. ]

Estimated Enrollment: 80
Study Start Date: July 2006
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Preoperative MRI of the brain
Determining if the results of fMRI is precise enough for preoperative decision making in functional mapping of the brain.
Procedure: Presurgical MRI
MRI of the Brain

Detailed Description:
The purpose of this study is to determine if fMRI is precise enough to be used in preoperative decision making for patients who have brain tumors. Before a patient has brain surgery to have the tumor removed, functional mapping of the brain takes place either intra-operatively or post operatively after a subdural grid implant has been placed. Mapping helps the surgeon determine which areas of the brain are responsible for different important body functions. During this mapping procedure the surgeon determines if they can safely remove all or part of a brain tumor. The investigators are hoping to show that fMRI is just as accurate in mapping out different areas of the brain, without having to utilize an invasive form of brain mapping.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • All patients with brain tumors and healthy volunteers

Exclusion Criteria:

  • If patients are pregnant.
  • If patients suffer from a significant degree of claustrophobia.
  • If patients are claustrophobic and requires general anesthesia to complete the diagnostic MRI.
  • Contraindications for an MRI due to surgeries and/or implantation of pacemakers or pacemaker wires, open heart surgery for placement of an artificial heart valve, brain aneurysm surgery, middle ear implants, hearing aids, braces or extensive dental work, cataract surgery or lens implant, any implanted mechanical or electrical device, implanted neurological stimulators or artificial limbs or joints.
  • Contraindications from an MRI due to foreign metallic objects in the body such as: bullets, BBs, pellets, surgical magnetic metal clips, joint or bone pins, metal plates, shrapnel or any one who has a history of working near metal who could have metal shavings in their eyes.
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Please refer to this study by its identifier: NCT00724737

United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Principal Investigator: Boklye Kim, M.D. University of Michigan
  More Information

Responsible Party: Boklye Kim, M.D., University of Michigan Health System Identifier: NCT00724737     History of Changes
Other Study ID Numbers: 1999-0643
Study First Received: July 25, 2008
Last Updated: August 4, 2011 processed this record on April 21, 2017