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

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Boklye Kim, University of Michigan
ClinicalTrials.gov Identifier:
NCT00724737
First received: July 25, 2008
Last updated: May 16, 2017
Last verified: May 2017
  Purpose
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

Condition Intervention
Brain Tumors Procedure: Presurgical MRI Procedure: functional MRI (fMRI) of the brain

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Diagnostic
Official Title: Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors

Further study details as provided by Boklye Kim, University of Michigan:

Primary Outcome Measures:
  • Determining whether fMRI mapping is as effective as invasive presurgical mapping. [ Time Frame: 2 weeks ]
    Subjects will be followed for the duration of their hospital stay with an expected average of 2 weeks.


Enrollment: 23
Actual Study Start Date: July 2006
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724737

Locations
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Boklye Kim, M.D. University of Michigan
  More Information

Responsible Party: Boklye Kim, Primary Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00724737     History of Changes
Other Study ID Numbers: HUM 00050205
NIH
Study First Received: July 25, 2008
Last Updated: May 16, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

ClinicalTrials.gov processed this record on July 28, 2017