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

NCT00724737 | Completed

• 2 other identifiers: HUM 00050205NIH
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Brain Tumors

Outcome Measures

Primary Outcomes (1)

• Determining whether fMRI mapping is as effective as invasive presurgical mapping.

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

  2 weeks

Study Arms (2)

fMRI of the brain, no surgery

ACTIVE COMPARATOR

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

Procedure: functional MRI (fMRI) of the brain

fMRI of the brain, presurgical

EXPERIMENTAL

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

Procedure: Presurgical MRI

Interventions

Presurgical MRI PROCEDURE

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.

fMRI of the brain, presurgical

functional MRI (fMRI) of the brain PROCEDURE

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.

fMRI of the brain, no surgery

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with brain tumors and healthy volunteers

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Boklye Kim, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: July 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 18, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)