Presurgical Planning With Functional MRI (fMRI) Mapping of Motor Cortex in Patients With Cerebral Tumors
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain Tumors |
Procedure: Presurgical MRI |
Phase 0 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors |
- Determining whether fMRI mapping is as effective as invasive presurgical mapping. [ Time Frame: Time of procedure. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2006 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Procedure: Presurgical MRI
MRI of the Brain
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United States, Michigan | |
| University of Michigan Health System | |
| Ann Arbor, Michigan, United States, 48109 | |
| Principal Investigator: | Boklye Kim, M.D. | University of Michigan Health System |
More Information
No publications provided
| Responsible Party: | Boklye Kim, M.D., University of Michigan Health System |
| ClinicalTrials.gov Identifier: | NCT00724737 History of Changes |
| Other Study ID Numbers: | 1999-0643, NIH, NCI |
| Study First Received: | July 25, 2008 |
| Last Updated: | August 4, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013