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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT00724737
Collaborator
National Cancer Institute (NCI) (NIH), National Institutes of Health (NIH) (NIH)
23
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Study Details

Study Description

Brief Summary

The purpose of this study is to determine if functional MRI is precise enough to provide information about the location of brain functions in patients who have brain tumors. This might allow physicians to use a non-invasive procedure to assist with brain mapping prior to surgery

Condition or Disease Intervention/Treatment Phase
  • Procedure: Presurgical MRI
  • Procedure: functional MRI (fMRI) of the brain
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors
Actual Study Start Date :
Jul 1, 2006
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: fMRI of the brain, no surgery

Healthy volunteers will undergo an fMRI (functional MRI of the brain).

Procedure: functional MRI (fMRI) of the brain
Healthy subjects will be undergo a brain fMRI of the brain. fMRI is a "functional" scan, meaning that subjects will be asked to perform tasks (such as finger tapping or picture identification) during the MRI scan.

Experimental: fMRI of the brain, presurgical

Patients scheduled to have brain surgery will undergo an fMRI (functional MRI of the brain).

Procedure: Presurgical MRI
People who are scheduled to have brain surgery with undergo a fMRI of the brain before surgery. This is a "functional" scan, meaning that subjects will be asked to perform tasks (such as finger tapping or picture identification) during the MRI scan.

Outcome Measures

Primary Outcome Measures

  1. Determining whether fMRI mapping is as effective as invasive presurgical mapping. [2 weeks]

    Subjects will be followed for the duration of their hospital stay with an expected average of 2 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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)

Investigators

  • Principal Investigator: Boklye Kim, M.D., University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Boklye Kim, Primary Investigator, University of Michigan
ClinicalTrials.gov Identifier:
NCT00724737
Other Study ID Numbers:
  • HUM 00050205
  • NIH
First Posted:
Jul 29, 2008
Last Update Posted:
May 18, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 18, 2017