Clinical trial NCT03604302: Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tumors
Official title: Identification of Essential Areas of the Brain in Pre-Operative Brain Tumor Patients Using BOLD fMRI and Independent Physiological Parameters
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Tumor
Keywords: Functional Magnetic Resonance Imaging (fMRI)
18-331
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
First posted: 2018-07-27
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Primary outcomes:
measure: Number of patients that have false negative results
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrei Holodny, MD
role: PRINCIPAL_INVESTIGATOR
References: