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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

July 25, 2008

Last Updated Date

July 28, 2008

Start Date ^†

July 2006

Current Primary Outcome Measures ^†

Determining whether fMRI mapping is as effective as invasive presurgical mapping. [ Time Frame: Time of procedure. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00724737 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

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

Brief Summary

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.

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.

Study Phase

Phase 0

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Open Label, Uncontrolled, Single Group Assignment

Condition ^†

Brain Tumors

Intervention ^†

Procedure: functional MRI

Study Arms / Comparison Groups

Experimental: Determining if the results of fMRI is precise enough for preoperative decision making in functional mapping of the brain.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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 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.

Gender

Both

Ages

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00724737

Responsible Party

Boklye Kim, M.D., University of Michigan Health System

Secondary IDs ^††

NIH, NCI

Study Sponsor ^†

University of Michigan

Collaborators ^††

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators ^†

Principal Investigator:

Boklye Kim, M.D.

University of Michigan Health System

Information Provided By

University of Michigan

Verification Date

July 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.