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. (Hercules)

A Multi-Site Prospective, Single-Arm, Observational Study On The Accuracy Of Whole Body Magnetic Resonance Imaging (Wb-Mri) Screening To Predict Clinically Significant Diagnoses In General Population Subjects Interested In Proactive And Advanced General Preventive Healthcare.

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Aneurysm; Neurologic Disorder; Metabolic Disease
• Intervention / Treatment: Diagnostic test: MRI Scan

• Study Type: Observational
• Enrollment (Estimated): 100000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kayla MacLeod, BS; Phone Number: (301) 450-4451; Email: kayla.macleod@herculesstudy.org

Study Locations

• United States
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Recruiting
      • Hercules Research Center
      • Contact: Sarah Hemeon, BS; Phone Number: 617-203-7565; Email: hello@herculesstudy.org
      • Contact: Gerimar Leon, BS; Phone Number: (617) 362-3570; Email: gerimar.leon@herculesstudy.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

All the patients above 18 years of age.

Description

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 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 Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MRI Scan Arm; Whole Body MRI Scan	Diagnostic test: MRI Scan; Whole Body MRI Scan

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Endpoint of ONCO-RADS Score (Oncological relevant findings reporting and data system) diagnosed in the follow-up period, including but not limited to, types of cancers, aneurysms, metabolic disorders, neurologic disorders, renal function, etc	Additionally, for the purposes of more specifically distinguishing CSD's of oncological-concern, following the ONCO-RADS7 guidelines for cancer screening utilizing WB-MRI, an additional ONCO-RADS score tag ("ONCO") will be attached to each CSD to reflect oncologic-specific risk according to the screening WB-MRI criteria. Higher the number worse the risk of having Cancer.	Up to 10 Years

Collaborators and Investigators

• Sponsor: Hercules
• Collaborators: Prenuvo Inc
• Investigators: Principal Investigator: Perry Kaneriya, MD, MBA, Hercules

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2037

Study Registration Dates

• First Submitted: December 26, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 30, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Metabolic Diseases
• Other Study ID Numbers: MA- 001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No