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

Brain Tumors Clinical Trial

Official title:

Presurgical Planning With Motion Corrected fMRI Mapping of Motor Cortex in Patients With Cerebral Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00724737
• Other study ID #: HUM 00050205
• Secondary ID: NIH
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: May 16, 2017
• Start date: July 2006
• Est. completion date: December 2013

Study information

• Verified date: May 2017
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Tumors

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan Health System	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining whether fMRI mapping is as effective as invasive presurgical mapping.	Subjects will be followed for the duration of their hospital stay with an expected average of 2 weeks.	2 weeks