fMRI for Brain Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Neurological, Psychiatric, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new brain imaging method using breath-holding functional magnetic resonance imaging (BH fMRI). The researchers aim to determine if adding BH fMRI to standard MRI scans provides better or similar results for brain cancer patients. Eligible participants include those with a brain tumor suspected or confirmed to affect speech or motor areas, as identified on an MRI. Participants must be comfortable performing tasks like holding their breath during the scan. The study requires only a few extra minutes during a routine MRI. As an unphased study, it offers patients the chance to contribute to innovative imaging techniques that could enhance future brain cancer diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this imaging technique is safe for brain cancer patients?

Research shows that functional magnetic resonance imaging (fMRI), like the one used in this study, safely and non-invasively examines brain activity. Studies have found that fMRI is comfortable for patients and does not use any radiation, unlike some other scans.

Previous research has used fMRI in brain tumor cases and found it generally safe, with no major side effects reported. It is particularly helpful because it allows doctors to see which parts of the brain are active during certain tasks. In this study, the breath-holding fMRI (BH fMRI) adds only about five minutes to the usual scan time, which is minimal and does not increase risk.

Overall, fMRI has been safely used for many years in brain studies, and this study is expected to maintain that safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using fMRI paradigms for brain cancer because it offers a non-invasive way to gather detailed information about brain activity and blood flow. Unlike traditional imaging techniques, fMRI can help map brain functions more precisely, which is crucial for planning surgeries and other treatments. This method uses a breath-holding fMRI paradigm that could enhance the accuracy of identifying critical brain areas, potentially leading to better outcomes for patients. By improving how brain regions are visualized and understood, it holds promise for personalizing treatment strategies and minimizing harm to essential brain functions.

What evidence suggests that using BH fMRI is effective for brain cancer imaging?

Research shows that functional magnetic resonance imaging (fMRI), which participants in this trial will undergo, can be useful in cases of brain tumors, especially for planning surgeries. Studies have found that fMRI can connect brain activity patterns with how well patients regain language skills after surgery. This means fMRI might help doctors plan surgeries more effectively by identifying important areas of the brain. Additionally, advanced fMRI techniques combined with deep learning models have shown promise in accurately detecting brain tumors. Overall, fMRI provides valuable insights that could improve surgical outcomes for brain cancer patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Andrei Holodny, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults aged 18-80 with brain tumors near areas responsible for speech or movement, who can follow language tasks during an MRI scan. It's not suitable for those with claustrophobia, anxiety preventing MRI exams, pacemakers (unless MRI safe), pregnant/nursing women, and individuals unable to perform required tasks due to physical or cognitive limitations.

Inclusion Criteria

I can follow language tasks as instructed during a scan.

I can follow language tasks as instructed while in a scanner.

I am a woman who can have children and have a negative pregnancy test.

Exclusion Criteria

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.)

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.)

I can follow instructions and perform tasks as asked during a scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo routine pre-operative MRI including task-based fMRI and perfusion data acquisition, with an additional 5 minutes for breath-holding fMRI (BH fMRI) for research purposes

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• fMRI Paradigms

Trial Overview The study tests the accuracy of breath-holding fMRI compared to standard imaging in locating brain functions affected by tumors. Researchers aim to determine if this additional imaging technique provides better results than the current standard alone.

How Is the Trial Designed?

Group I: Functional Magnetic Resonance Imaging (fMRI) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

A study involving 76 newly diagnosed breast cancer patients and 50 healthy controls found that baseline resting state fMRI can predict cognitive impairments, such as executive dysfunction and memory issues, after chemotherapy treatment.

Patients undergoing chemotherapy experienced a significant increase in executive dysfunction and a decrease in memory function over time, highlighting the potential for early neuroimaging assessments to identify those at risk for cognitive decline and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Patient Reported Outcomes of Cognitive Function Using Connectome-Based Predictive Modeling in Breast Cancer. Henneghan, AM., Gibbons, C., Harrison, RA., et al.[2021]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2405844025008448

Systematic review of functional magnetic resonance ... Association of functional magnetic resonance imaging indices with postoperative language outcomes in patients with primary brain tumors.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10453020/

Brain Tumor Detection Based on Deep Learning Approaches ... Our proposed deep learning model showed promising results, accurately identifying the presence and precise location of brain tumors in MRI images.

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rycan.230078

Current State of Functional MRI in the Presurgical Planning ... Association of functional magnetic resonance imaging indices with postoperative language outcomes in patients with primary brain tumors.

4. nature.com nature.com/articles/sdata20163

A structural and functional magnetic resonance imaging ... We collected high resolution structural (T1, T2, DWI) and several functional (BOLD T2*) MRI data in 22 patients with different types of brain tumours.

5. tandfonline.com tandfonline.com/doi/full/10.2147/JMDH.S470809

Systematic Review Between Resting-State fMRI and Task ... The advent of functional magnetic resonance imaging (fMRI) has transformed the practice of neurosurgery by offering unparalleled insights into the brain's ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/19148037/

Functional magnetic resonance imaging-guided brain ... Objectives: We evaluated the safety and efficacy of using functional magnetic resonance imaging (fMRI) brain activation data obtained at both 1.5 and 3 T to ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10698604/

Current State of Functional MRI in the Presurgical Planning of ... This review highlights the current state of functional MRI for preoperative assessment in patients undergoing surgical intervention for brain tumors.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03604302

Study Details | NCT03604302 | Evaluation of Preoperative ... 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 ...

9. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.222028

Functional MRI in Neuro-Oncology: State of the Art and ... This review discusses clinical fMRI in neuro-oncology, relevant ongoing research topics, and prospective future developments in this exciting discipline.