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

Not Applicable

Completed

• Conditions: Brain Tumors
• Interventions: Procedure: Presurgical MRI; Procedure: functional MRI (fMRI) of the brain

• Registration Number: NCT00724737
• Lead Sponsor: University of Michigan

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

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 Timeline

• Study Start: 2006-07
• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
fMRI of the brain, presurgical	Presurgical MRI	Patients scheduled to have brain surgery will undergo an fMRI (functional MRI of the brain).
fMRI of the brain, no surgery	functional MRI (fMRI) of the brain	Healthy volunteers will undergo an fMRI (functional MRI of the brain).

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States