Brain TumorNCT03604302
Evaluation of Preoperative Functional Magnetic Resonance Imaging (fMRI) in Patients With Brain Tumors
A study testing fMRI Paradigms in people with Brain Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumor
- What is being tested?
- fMRI Paradigms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Identification of Essential Areas of the Brain in Pre-Operative Brain Tumor Patients Using BOLD fMRI and Independent Physiological Parameters
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.
- Conditions
- Brain Tumor
- Being tested
- fMRI Paradigms
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), 18-331
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI ParadigmsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) | Experimental | 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. Receives: Device: fMRI Paradigms |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start1 Aug 2018
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Andrei Holodny, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03604302
- Sponsor's protocol ID
- 18-331
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2018
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Essential Areas of the Brain in Pre-Operative Brain Tumor Patients Using BOLD fMRI and Independent Physiological Parameters
- ClinicalTrials.gov ID
- NCT03604302
- Acronym / sponsor ID
- 18-331
- Conditions
- Brain Tumor
- Keywords
- Functional Magnetic Resonance Imaging (fMRI), 18-331
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 27 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Magnetic Resonance Imaging (fMRI) | Experimental | Device: fMRI ParadigmsThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI ParadigmsT2*-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. | Device | Functional Magnetic Resonance Imaging (fMRI) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Holodny, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI Paradigms in people with Brain Tumor, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients that have false negative results (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.