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ACTIVE NOT RECRUITING

NCT03604302

Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tumors

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to test the accuracy of using an imaging technique called breath-holding functional magnetic resonance imaging (BH fMRI) in addition to the standard imaging test described above. This study will allow the researchers to find out whether using BH fMRI in combination with the standard approach is the same as, better, or worse than the standard approach used alone.

Official title: Identification of Essential Areas of the Brain in Pre-Operative Brain Tumor Patients Using BOLD fMRI and Independent Physiological Parameters

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2018-08-01

Completion Date

2026-07

Last Updated

2025-10-14

Healthy Volunteers

Yes

Conditions

Brain Tumor

Interventions

DEVICE

fMRI Paradigms

T2\*-weighted images will be acquired with a single-shot gradient echo echo-planar imaging (EPI) sequence in the axial orientation (TR=2500ms, TE=30ms, FA=80°, slice thickness=4 mm, FOV= 240mm2, matrix=64×64) covering the whole brain.

Inclusion Criteria: Health Volunteers * Volunteers between the ages of 18 and 80 years * Volunteers must be able to perform the language paradigms on cue while inside the scanner Patients * Patients between the ages of 18 and 80 years * Patients must be able to perform the language paradigms on cue while inside the scanner * Women of child bearing potential must have a negative pregnancy test prior to the study intervention (Serum or Urine) * Patients diagnosed with primary glial neoplasm, meningioma and metastasis (from prior histology) or must be suspected to have primary glial neoplasm, meningioma and metastasis on imaging (to be confirmed by post-operative histology). * Patient"s location of the tumor must involve the expected location of Broca"s area (left pars opercularis and/or pars triangularis), or the expected location of the primary motor area (the pre-central gyrus). This determination will be made on the basis of a pre-operative MRI by a fellowship-trained Neuroradiologist Exclusion Criteria: Healthy Volunteers * Volunteers who are unable to comply or complete MRI exams as per the site"s standards. (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.) o MSK site only - see Appendix 2 * Volunteers who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.) * Volunteers with a history of neurological disorders, psychiatric disorders or cancer Female volunteers who are pregnant or nursing. * Volunteers who have MRI safe pacemakers. * Volunteers from the vulnerable population, as defined by 45 CFR 46 * Volunteers who are unable to perform the breath hold task during practice sessions Patients * Patients who are unable to comply or complete MRI exams as per the site"s standards. (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.) °MSK site only - see Appendix 2 * Patients who have MRI safe pacemakers. * Patient who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.) * Female patients who are pregnant or nursing. * Patients from the vulnerable population, as defined by 45 CFR 46 * Patients who are unable to perform the breath hold task during practice sessions

Locations (1)

Memorial Sloan Kettering Cancer Center

New York, New York, United States