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

Brain Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03604302
• Other study ID #: 18-331
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: July 2025

Study information

• Verified date: January 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor

Intervention

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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Memorial Sloan Kettering Cancer Center