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

Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors

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

Study Overview

• Status: Completed
• Conditions: Brain Tumors
• Intervention / Treatment: Procedure: functional MRI (fMRI) of the brain; Procedure: Presurgical MRI

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Boklye Kim, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2006
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Actual): May 18, 2017
• Last Update Submitted That Met QC Criteria: May 16, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: HUM 00050205; NIH (NIH U19 AI 90023)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO