Using whole-body MRI to identify significant health issues in the general population

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 study is testing if whole-body MRI scans can help find serious health problems like cancer and heart issues in people aged 18 and older.

Quick facts

• Study type: Observational
• Enrollment: 100000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hercules (Industry-sponsored)
• Locations: 1 site (Watertown, Massachusetts)
• Trial ID: NCT06212479 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the accuracy of whole-body magnetic resonance imaging (WB-MRI) in predicting clinically significant diagnoses among a diverse group of participants aged 18 and older. Up to 100,000 subjects will be recruited from multiple clinical sites across the United States, with careful adherence to inclusion and exclusion criteria. Participants will undergo WB-MRI scans, and data will be collected to assess the effectiveness of this screening method in identifying conditions such as cancer, metabolic diseases, aneurysms, and neurologic disorders.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are interested in proactive healthcare and meet the study's inclusion criteria.

Not a fit: Patients with contraindicated medical devices or those who are pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance early detection of serious health conditions, leading to improved patient outcomes.

How similar studies have performed: While the use of WB-MRI for screening is gaining interest, this specific approach is relatively novel and has not been extensively tested in large populations.

Eligibility criteria

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.

Where this trial is running

Watertown, Massachusetts

• Hercules Research Center — Watertown, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Perry Kaneriya, MD, MBA — Hercules
• Study coordinator: Kayla MacLeod, BS

Conditions Cancer; Metabolic Disease; Aneurysm; Neurologic Disorder