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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03604302
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : December 6, 2019
Sponsor:
Collaborator:
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Brain Tumor Device: fMRI Paradigms Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Identification of Essential Areas of the Brain in Pre-Operative Brain Tumor Patients Using BOLD fMRI and Independent Physiological Parameters
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Number of patients that have false negative results [ Time Frame: 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03604302


Contacts
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Contact: Andrei Holodny, MD 212-639-3182 holodnya@mskcc.org
Contact: Kyung Peck, MSc, PhD 212-639-8522

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrei Holodny, MD    212-639-3182      
Contact: Kyung Peck, PhD         
Principal Investigator: Andrei Holodny, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Andrei Holodny, MD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03604302    
Other Study ID Numbers: 18-331
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Memorial Sloan Kettering Cancer Center:
Functional Magnetic Resonance Imaging (fMRI)
18-331
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases