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

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University of Michigan

Status

Completed

Conditions

Brain Tumors

Treatments

Procedure: Presurgical MRI
Procedure: functional MRI (fMRI) of the brain

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00724737
HUM 00050205
NIH

Details and patient eligibility

About

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

Full 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.

Enrollment

23 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

23 participants in 2 patient groups

fMRI of the brain, no surgery
Active Comparator group
Description:
Healthy volunteers will undergo an fMRI (functional MRI of the brain).
Treatment:
Procedure: functional MRI (fMRI) of the brain
fMRI of the brain, presurgical
Experimental group
Description:
Patients scheduled to have brain surgery will undergo an fMRI (functional MRI of the brain).
Treatment:
Procedure: Presurgical MRI

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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