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

33 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment fMRI Paradigms for brain cancer?

Research shows that fMRI can help map brain activity in patients with brain tumors, which is useful for planning surgeries to avoid damaging important brain areas. This suggests that fMRI is effective in identifying functional brain regions, potentially preserving brain function during treatment. ^{1 2 3 4 5}

Is fMRI safe for use in brain cancer patients?

fMRI is generally considered safe for use in humans, including brain cancer patients, as it is a noninvasive imaging technique. Studies show that using fMRI for preoperative planning in brain tumor surgeries can reduce the risk of complications after surgery. ^{4 6 7 8 9}

How is fMRI used as a treatment for brain cancer different from other treatments?

fMRI (functional magnetic resonance imaging) is unique because it helps doctors plan brain surgery by showing which parts of the brain are active and need to be avoided during tumor removal. This is different from other treatments that directly target the tumor, as fMRI is used to protect important brain functions during surgery. ^{2 4 10 11 12}

Research Team

Andrei Holodny, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Preoperative blood oxygen level-dependent functional magnetic resonance imaging in patients with primary brain tumors: clinical application and outcome. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

BOLD signal in the motor cortex shows a correlation with the blood volume of brain tumors. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Functional magnetic resonance imaging of regional brain activity in patients with intracerebral gliomas: findings and implications for clinical management. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Reliability of Task-Based fMRI for Preoperative Planning: A Test-Retest Study in Brain Tumor Patients and Healthy Controls. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Characterization of BOLD-fMRI signal during a verbal fluency paradigm in patients with intracerebral tumors affecting the frontal lobe. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Can Preoperative Mapping with Functional MRI Reduce Morbidity in Brain Tumor Resection? A Systematic Review and Meta-Analysis of 68 Observational Studies. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of a clinical fMRI cueing system utilizing complex scene and auditory stimuli for neurosurgical treatment planning of patients with cognitive and physical deficits. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Functional MRI studies in non-CNS cancers. [2013]

9. United States pubmed.ncbi.nlm.nih.gov

Predicting Patient Reported Outcomes of Cognitive Function Using Connectome-Based Predictive Modeling in Breast Cancer. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Pneumatic artificial muscle-based stimulator for passive functional magnetic resonance imaging sensorimotor mapping in patients with brain tumours. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

BOLD-MRI of breast invasive ductal carcinoma: correlation of R2* value and the expression of HIF-1α. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Functional MRI in Neuro-Oncology: State of the Art and Future Directions. [2023]