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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00724737
Enrollment
23
Registered
2008-07-29
Start date
2006-07-31
Completion date
2013-12-31
Last updated
2017-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumors

Brief 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

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.

Interventions

PROCEDUREPresurgical 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.

PROCEDUREfunctional 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.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
National Institutes of Health (NIH)
CollaboratorNIH
University of Michigan
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
Determining whether fMRI mapping is as effective as invasive presurgical mapping.2 weeksSubjects will be followed for the duration of their hospital stay with an expected average of 2 weeks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026