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

Sponsors and Collaborators:	University of Michigan National Cancer Institute (NCI) National Institutes of Health (NIH)
Information provided by:	University of Michigan
ClinicalTrials.gov Identifier:	NCT00724737

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: functional MRI	Phase 0

MedlinePlus related topics: Brain Cancer Cancer Childhood Brain Tumors

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors

Further study details as provided by University of Michigan:

Primary Outcome Measures:

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

Arms	Assigned Interventions
A: Experimental Determining if the results of fMRI is precise enough for preoperative decision making in functional mapping of the brain.	Procedure: functional MRI preoperative fMRI for mapping 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. We 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

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 anethesia 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 degive, implanted neurological stimulators or artificial limbs or joints.
Contraindicaitons from an MRI due to forgeign 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 netal who could have metal shavings in their eyes.

Contacts and Locations

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 Health System

More Information

Responsible Party:	University of Michigan Health System ( Boklye Kim, M.D. )
Study ID Numbers:	1999-0643, NIH, NCI
Study First Received:	July 25, 2008
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00724737
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009