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

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00724737
First received: July 25, 2008
Last updated: August 4, 2011
Last verified: August 2011
  Purpose

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
Phase 0

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

Resource links provided by NLM:


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. ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00724737

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Boklye Kim, M.D. University of Michigan
  More Information

No publications provided

Responsible Party: Boklye Kim, M.D., University of Michigan Health System
ClinicalTrials.gov Identifier: NCT00724737     History of Changes
Other Study ID Numbers: 1999-0643, NIH, NCI
Study First Received: July 25, 2008
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014