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.

Last updated: April 28, 2025
Sponsor: Hercules
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neurologic Disorders

Aneurysm

Cancer

Treatment

MRI Scan

Clinical Study ID

NCT06212479
MA- 001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a prospective, single-arm, observational study capturing data from whole-body magnetic resonance imagining (WB-MRI) from up to 100,000 male and female subjects 18 years of age or older recruited at multiple clinical sites within the United States. Study subjects must meet a set of inclusion and exclusion criteria. Potential subjects arriving at the study sites will be evaluated for enrollment. It is the Principal Investigator's (PI) responsibility to enroll only subjects who satisfy the inclusion/exclusion criteria. Recruitment can occur by subject presentation at the sites for elective standard screening, word-of-mouth, flyers, healthcare professional (HCP) referrals, advertisement online, or any other means, subject to approval by the associated institutional review board (IRB) or ethics committee (EC) when applicable.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 breathingand 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 costof the WBMRI acquisition procedure and interpretation;

  • Complete all required consent procedures.

Exclusion

Exclusion Criteria:

  • Harbor within their bodies contraindicated medical devices including, but notlimited to, implanted pacemakers, intracranial aneurysm clips, cochlear implants,drug infusion pumps, neurostimulators, bone growth stimulators, certain intrauterinecontraceptive 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 othercovered dedicated diagnostic imaging evaluations when such covered proceduresrepresent more appropriate or standard-of-care procedures by context-specificclinical indication;

  • Be an employee of the study site or the sponsor;

  • Have a medical condition or serious intercurrent illness, or other circumstancethat, in the Investigator's judgment, could jeopardize the candidate's safetyas a study subject, or that could interfere with study objectives.

Study Design

Total Participants: 100000
Treatment Group(s): 1
Primary Treatment: MRI Scan
Phase:
Study Start date:
May 17, 2024
Estimated Completion Date:
January 31, 2037

Connect with a study center

  • Hercules Research Center

    Watertown, Massachusetts 02472
    United States

    Active - Recruiting

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