Back to resultsPresurgical Planning With Functional MRI (fMRI) Mapping of Motor Cortex in Patients With Cerebral Tumors
Primary Purpose
Brain Tumors
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Presurgical MRI
functional MRI (fMRI) of the brain
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Tumors
Eligibility Criteria
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.
Sites / Locations
- University of Michigan Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
fMRI of the brain, no surgery
fMRI of the brain, presurgical
Arm Description
Healthy volunteers will undergo an fMRI (functional MRI of the brain).
Patients scheduled to have brain surgery will undergo an fMRI (functional MRI of the brain).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00724737
First Posted
July 25, 2008
Last Updated
May 16, 2017
Sponsor
University of Michigan
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT00724737
Brief Title
Presurgical Planning With Functional MRI (fMRI) Mapping of Motor Cortex in Patients With Cerebral Tumors
Official Title
Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
July 2006 (Actual)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
4. Oversight
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
fMRI of the brain, no surgery
Arm Type
Active Comparator
Arm Description
Healthy volunteers will undergo an fMRI (functional MRI of the brain).
Arm Title
fMRI of the brain, presurgical
Arm Type
Experimental
Arm Description
Patients scheduled to have brain surgery will undergo an fMRI (functional MRI of the brain).
Intervention Type
Procedure
Intervention Name(s)
Presurgical MRI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
functional MRI (fMRI) of the brain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determining whether fMRI mapping is as effective as invasive presurgical mapping.
Description
Subjects will be followed for the duration of their hospital stay with an expected average of 2 weeks.
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boklye Kim, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Presurgical Planning With Functional MRI (fMRI) Mapping of Motor Cortex in Patients With Cerebral Tumors
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