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Observational Study on Whole-Body MRI Screening for Early Disease Detection

This study is looking at how well whole-body magnetic resonance imaging (WB-MRI) can find important health problems like cancer, metabolic disease, aneurysms, and neurologic disorders in people who are generally healthy. Researchers want to see if WB-MRI can accurately predict these conditions. You can join if you are 18 years or older and can follow study instructions. The study aims to enroll up to 100,000 people across the United States. The main goal is to see how many clinically significant diseases are found after the WB-MRI scan, with follow-up for up to 10 years.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include up to 100,000 participants.
What's involved
You would undergo a whole-body MRI scan and need to be able to follow breathing and movement instructions during the scan. You will also provide clinical, demographic, and medical information.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 10 years to see if any clinically significant diseases are diagnosed.

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NCT06212479

An Observational Study On TheAccuracy Of Whole-Body Magnetic Resonance Imaging (Wb-Mri) ScreeningTo Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.

Recruiting
Not specifiedAges 18+Observational
Hercules
~100,000 participants
Updated 2025-04-30 on ClinicalTrials.gov
What's tested:MRI Scan

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Endpoint and 5-point scale of CSD (Clinically Significant Disease) of CSD diagnosed post-baseline in general population subjects.
Measured over Up to 10 Years

Conditions

Cancer
Metabolic Disease
Aneurysm
Neurologic Disorder

Explore related trials

AneurysmMalignant NeoplasmMetabolic DisorderNervous System Disorder

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Perry Kaneriya, MD, MBA · PRINCIPAL_INVESTIGATOR · Hercules

Who to contact

Kayla MacLeod, BS
[email protected]
(301) 450-4451
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Each subject MUST:
Be\>=18 years of age at the time of enrollment.
Be able to read and understand provided procedural information for the study;
Be able and willing to follow all study procedures including proper breathing and body movement minimization while within the WB-MRI system;
Be willing and able to provide required clinical, demographic, medical history, and concomitant medications information;
Be able to provide financial payment in advance for reimbursement of the cost of the WBMRI acquisition procedure and interpretation;
Complete all required consent procedures.

Exclusion

Harbor within their bodies contraindicated medical devices including, but not limited to, implanted pacemakers, intracranial aneurysm clips, cochlear implants, drug infusion pumps, neurostimulators, bone growth stimulators, certain intrauterine contraceptive devices, non- MRI safe metals, etc.;
Self-certify that they are pregnant;
Be seeking to undergo WB-MRI as a subject in this study in lieu of other covered dedicated diagnostic imaging evaluations when such covered procedures represent more appropriate or standard-of-care procedures by context-specific clinical indication;
Be an employee of the study site or the sponsor;
Have a medical condition or serious intercurrent illness, or other circumstance that, in the Investigator's judgment, could jeopardize the candidate's safety as a study subject, or that could interfere with study objectives.

What this trial measures

  • Primary Endpoint and 5-point scale of CSD (Clinically Significant Disease) of CSD diagnosed post-baseline in general population subjects.Up to 10 Years

    Clinically significant disease represents the primary output of WB-MRI image analysis, and thus, the primary endpoint for this study. This outcome will be expressed as a 5-point scale similar to the standard Likert scale used in clinical studies. Higher the number higher the risk of clinically significant finding.