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Active, not recruitingNCT03604302Updated Aug 5, 2026

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

An interventional study of fMRI Paradigms in Brain Tumor, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
33
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Brain Tumor

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Keywords

  • Functional Magnetic Resonance Imaging (fMRI)
  • 18-331
03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 33 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
33 participants (actual)

Study arms

  • 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

Interventions

  • DevicefMRI 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

07

Study locations

1 site
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03604302
Lead sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Weill Medical College of Cornell University
Responsible party
Sponsor
First posted
Jul 27, 2018
Start date
Aug 1, 2018
Primary completion
Jul 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Aug 5, 2026

Study contacts

Andrei Holodny, MD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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