Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tumors
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|ClinicalTrials.gov Identifier: NCT03604302|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : December 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumor||Device: fMRI Paradigms||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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
|Contact: Andrei Holodny, MDemail@example.com|
|Contact: Kyung Peck, MSc, PhD||212-639-8522|
|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|
|Principal Investigator:||Andrei Holodny, MD||Memorial Sloan Kettering Cancer Center|