Advanced MRI Techniques for Healthy Subjects

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

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

Compensation: Varies

Number of Visits: Unknown

461 Participants Needed

Trial Summary

What is the purpose of this trial?

Magnetic resonance imaging (MRI) is a diagnostic imaging method with constant progress and improvement in the way the MRI images are obtained. Many of these advances involve changes to MRI software and hardware. The goal of this study is to find out the possible benefits of new MRI techniques. This will allow us to use the new MRI methods in research and patient care.

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 Magnetic Resonance Imaging Acquisition and Analysis?

Advanced MRI techniques, like those used in high-field imaging, have shown promise in better understanding and diagnosing various brain disorders and conditions like multiple sclerosis. These techniques can provide more detailed images and reduce the time needed for scans, which can be beneficial in clinical settings. ^{1 2 3 4 5}

Is MRI generally safe for healthy humans?

MRI is generally considered safe for humans, even with repeated exposure, but some components like the magnetic field and radiofrequency pulses can cause temporary discomfort. Serious accidents are rare but can occur if safety guidelines are not followed. ^{6 7 8 9 10}

How does the treatment Magnetic Resonance Imaging Acquisition and Analysis differ from other treatments for this condition?

This treatment is unique because it uses advanced MRI techniques to acquire and analyze images, which can provide detailed insights into brain structure and function without the need for invasive procedures. Unlike other treatments, it focuses on improving image quality and acquisition speed, making it a non-invasive and efficient option for studying healthy subjects. ^{11 12 13 14 15}

Research Team

Oguz Akin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for men and women aged 18 or older who are in good health. It's not suitable for pregnant or nursing women, those considered vulnerable by specific regulations, anyone with conditions that make MRI unsafe like pacemakers, or individuals unable to complete an MRI due to anxiety issues.

Exclusion Criteria

Anyone who would be normally excluded from undergoing an MRI examination as per Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire for MRI

Patients/ volunteers from the vulnerable population, as defined by 45 CFR 46.

You have a pacemaker, aneurysm clip, or any other medical condition that prevents you from being exposed to strong magnetic fields.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Scan

Participants undergo an 'add-on' research MRI scan during their routine clinical MRI

Single session

Follow-up

Participants are monitored for safety and effectiveness after the MRI scan

4 weeks

Treatment Details

Interventions

• Magnetic Resonance Imaging Acquisition and Analysis

Trial Overview The study is testing new techniques of Magnetic Resonance Imaging (MRI) acquisition and analysis. The aim is to improve how MRI images are captured using updates in software and hardware, potentially benefiting research and patient care.

Participant Groups

Group I: MRI Experimental Treatment 2 Interventions

Add-On Research Patients will include patients who are scheduled for a routine clinical MRI who meet the eligibility requirements for this protocol. Protocol participation will consist of an "add-on" research. MRI scan, which will be performed any point during of the routine clinical MRI scan. Volunteers will be subjects expressing interest in participation and who meet the eligibility requirements for this protocol. No contrast enhanced research MRIs including gadolinium-based or other contrast agents will be performed in volunteers.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Ceretype

Collaborator

Trials

1

Recruited

460+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study involving 148,489 patients over 10 years, gadoteric acid (Dotarem®) was found to be a safe MRI contrast agent, with only 0.3% of patients experiencing adverse events, primarily mild symptoms like nausea and vomiting.

The diagnostic effectiveness was high, with 99.8% of examinations yielding useful results and excellent or good image quality in 97.7% of cases, indicating that gadoteric acid is effective for routine MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. Braun, J., Busse, R., Darmon-Kern, E., et al.[2020]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

MRI is generally safe for humans, even with repeated exposure, but certain components can cause temporary inconveniences or severe accidents if safety protocols are not followed.

The article reviews reported MRI accidents, explaining their mechanisms and emphasizing the importance of strict safety measures to prevent serious adverse effects, including potential fatalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Risks associated with MRI: safety rules, incidents, and accidents]. de Kerviler, E., de Bazelaire, C., Mathieu, O., et al.[2019]

Over a 10-year period, the FDA received 1568 reports of adverse events related to magnetic resonance (MR) systems, with 1548 reports analyzed, highlighting the importance of monitoring safety in MR imaging.

The most common serious injuries reported were thermal events, accounting for 59% of cases, followed by mechanical events (11%), projectile events (9%), and acoustic events (6%), indicating specific risks associated with MR environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI-related FDA adverse event reports: A 10-yr review. Delfino, JG., Krainak, DM., Flesher, SA., et al.[2020]

References

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

Current status and future perspectives of magnetic resonance high-field imaging: a summary. [2021]

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

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Advanced pediatric neuroimaging. [2023]

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Clinical Feasibility of Synthetic MRI in Multiple Sclerosis: A Diagnostic and Volumetric Validation Study. [2022]

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Discrimination between Malignant and Benign Vertebral Fractures Using Magnetic Resonance Imaging. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Baseline characteristics, diagnostic efficacy, and peri-examinational safety of IV gadoteric acid MRI in 148,489 patients. [2020]

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

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

8. France pubmed.ncbi.nlm.nih.gov

[Risks associated with MRI: safety rules, incidents, and accidents]. [2019]

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

Occurrence of adverse reactions to gadolinium-based contrast material and management of patients at increased risk: a survey of the American Society of Neuroradiology Fellowship Directors. [2015]

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

MRI-related FDA adverse event reports: A 10-yr review. [2020]

11. Japan pubmed.ncbi.nlm.nih.gov

[Basic principles of magnetic resonance imaging]. [2018]

12. Switzerland pubmed.ncbi.nlm.nih.gov

A Method for Whole Brain Ex Vivo Magnetic Resonance Imaging with Minimal Susceptibility Artifacts. [2022]

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Simultaneous acquisition of spatial harmonics (SMASH): fast imaging with radiofrequency coil arrays. [2022]

14. England pubmed.ncbi.nlm.nih.gov

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