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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Device: fMRI Paradigms

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Functional Magnetic Resonance Imaging (fMRI); The interventions for this study are non-invasive. For patients, routine pre-operative MRI that includes task based fMRI and perfusion data acquisition will be performed on a 3T scanner. Patients who participate in this study, will have approximately 5 minutes added to their scan time for the below described breath holding fMRI (BH fMRI) paradigm, which will be done for research purposes. For healthy volunteers, participation will involve having a high resolution anatomical MRI done with the same paradigms which patients will have, listed below. the total scanner time will be approximately 25 minutes, and the scan will not be billed to the healthy volunteer.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients that have false negative results	The primary objective is to examine if the false negative results of BOLD fMRI adjacent to brain tumors can be compensated for by measurements of BH-MRI and subsequent calibration of the BOLD response. We will have two sets of data: 1) the data obtained using routine techniques to analyze the BOLD fMRI data; and 2) the data obtained where the BOLD fMRI data was analyzed incorporating BH data. Every data point obtained in 1) will have a corresponding data point using 2), the BH MRI data, to adjust the BOLD fMRI analysis.	2 years

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Andrei Holodny, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 19, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Functional Magnetic Resonance Imaging (fMRI); 18-331
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 18-331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes