Advanced MRI Techniques for Healthy Subjects

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Pacemaker, Aneurysm clip, Pregnant, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test new magnetic resonance imaging (MRI) techniques to determine their benefits for research and patient care. It uses updated software and hardware to improve image quality during MRI scans. Participants will undergo an additional research MRI scan while already scheduled for a routine MRI. The trial seeks healthy adults scheduled for a routine MRI who have no metal implants, such as pacemakers, which could interfere with the MRI. As an unphased trial, it offers participants the chance to contribute to advancements in MRI technology that could enhance future 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 prior data suggests that these advanced MRI techniques are safe for healthy subjects?

Research has shown that MRI is generally safe for most people. Unlike X-rays or CT scans, it doesn't use radiation but instead employs strong magnets and radio waves to capture images of the body's interior. Before an MRI, patients undergo a safety check to identify metal implants or pacemakers, which the magnets could affect.

Studies have identified metal objects as the main safety concern, as MRI magnets can interfere with them. Therefore, following safety guidelines is crucial. People without metal implants or other contraindications typically handle the procedure well.

In this study, no contrast agents (dyes injected to highlight certain body parts) will be used, reducing any risk of allergic reactions. Overall, MRI is a noninvasive and safe imaging method for those who meet the safety requirements. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about advanced MRI techniques because they offer a more detailed and precise way of imaging the body without using contrast agents, which can sometimes cause side effects. Unlike traditional MRI methods that might rely on contrast agents for enhanced imaging, these advanced techniques aim to improve the clarity and accuracy of the scans through innovative acquisition and analysis methods. This means we could gain a clearer understanding of anatomical structures and potentially detect abnormalities earlier or more accurately, all while keeping the process safer for patients.

What evidence suggests that these advanced MRI techniques are effective for improving diagnostic imaging?

This trial will explore advanced MRI techniques for healthy subjects. Research has shown that new MRI techniques enhance understanding of complex medical conditions. Studies have found that these techniques produce detailed images of the body's tissues, aiding in the accurate diagnosis of tumors and other diseases. Advanced MRI also offers insights into how diseases affect the brain and movement disorders. These improved imaging methods allow doctors to see the size and location of tumors more clearly, aiding in treatment planning. Overall, these MRI advancements aim to make diagnosing and treating medical conditions more effective. ^{6 7 8 9 10}

Who Is on the Research Team?

Oguz Akin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8997011/

Advanced Magnetic Resonance Imaging (MRI) Techniques

It provides data on the tumor's size, location, and relationship to adjacent tissues. In addition, imaging can provide data on the biological ...

2.

sciencedirect.com

sciencedirect.com/topics/medicine-and-dentistry/magnetic-resonance-imaging-data-acquisition

Magnetic Resonance Imaging Data Acquisition - an overview

This review article summarizes some basic principles and recent developments in parallel imaging, a class of image reconstruction techniques for shortening ...

3.

medrxiv.org

medrxiv.org/content/10.1101/2022.07.06.22277151v1.full

Advanced MRI scan acquisition metrics improve baseline ...

This study looks at the predictive ability of common community MRI scans in comparison to high fidelity scans in disease diagnosis.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12080281/

MRIO: The magnetic resonance imaging acquisition and ...

MRIO provides well-reasoned classes and logical axioms for the acquisition of several MRI acquisition types and well-known, peer-reviewed analysis software.

5.

mdpi.com

mdpi.com/2076-3425/15/1/79

Advanced Magnetic Resonance Imaging for Early ...

Advanced magnetic resonance imaging (MRI) techniques are transforming the study of movement disorders by providing valuable insights into disease mechanisms.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10657250/

A Review of Magnetic Resonance (MR) Safety - PubMed Central

The MR safety guidelines still apply, but family members can accompany pediatric patients. Therefore, they need to undergo proper screening.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1687850725004078

Enhancing safety awareness: Assess magnetic resonance ...

This study aimed to investigate the Knowledge, Attitudes, and Practices (KAP) regarding MRI safety guidelines among healthcare students.

8.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK551669/

Magnetic Resonance Imaging Contraindications - NCBI - NIH

All patients must complete a thorough safety screening before undergoing an MRI scan due to potential safety risks. The screening process ...

9.

radiology.ucsf.edu

radiology.ucsf.edu/patient-care/patient-safety/mri

MRI Safety Guidelines: Screening & Implants

Prior to an MRI scan, patients will be screened for safety risks such as implantable devices (pacemakers, ICDs) or other metals that may cause interference.

10.

hopkinsmedicine.org

hopkinsmedicine.org/health/treatment-tests-and-therapies/magnetic-resonance-imaging-mri

Magnetic Resonance Imaging (MRI)

MRI is a noninvasive medical imaging test that produces detailed images of almost every internal structure in the human body, including the organs, bones, ...