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.

NCT06212479 | Recruiting

• 1 other identifier: MA- 001
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Metabolic Disease; Aneurysm; Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  Up to 10 Years

Study Arms (1)

MRI Scan Arm

Whole Body MRI Scan

Diagnostic Test: MRI Scan

Interventions

MRI Scan DIAGNOSTIC_TEST

Whole Body MRI Scan

MRI Scan Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients above 18 years of age.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hercules: lead
• Prenuvo Inc: collaborator

Study Sites (1)

Hercules Research Center

Watertown, Massachusetts, 02472, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Metabolic Diseases; Aneurysm; Nervous System Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Perry Kaneriya, MD, MBA

  Hercules

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kayla MacLeod, BS

CONTACT

(301) 450-4451; kayla.macleod@herculesstudy.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 18, 2024
• Study Start: May 17, 2024
• Primary Completion (Estimated): January 1, 2034
• Study Completion (Estimated): January 1, 2037
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

US (1)