Text Size

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:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00724737
First received: July 25, 2008
Last updated: August 4, 2011
Last verified: August 2011
History of Changes

July 25, 2008
August 4, 2011
July 2006
July 2011   (final data collection date for primary outcome measure)
Determining whether fMRI mapping is as effective as invasive presurgical mapping. [ Time Frame: Time of procedure. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00724737 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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 be used in preoperative decision making for patients who have brain tumors.

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.
Interventional
Phase 0
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Brain Tumors
Procedure: Presurgical MRI
MRI of the Brain
Experimental: Preoperative MRI of the brain
Determining if the results of fMRI is precise enough for preoperative decision making in functional mapping of the brain.
Intervention: Procedure: Presurgical MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2011
July 2011   (final data collection date for primary outcome measure)

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.
Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00724737
1999-0643, NIH, NCI
No
Boklye Kim, M.D., University of Michigan Health System
University of Michigan
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
Principal Investigator: Boklye Kim, M.D. University of Michigan Health System
University of Michigan
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP