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.

Launched by HERCULES · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of whole-body magnetic resonance imaging (WB-MRI) to find serious health conditions in people who want to take a proactive approach to their healthcare. The study aims to see how well WB-MRI can predict important health issues, like cancer, metabolic diseases, aneurysms, and neurological disorders, in people over 18 years old. Researchers are looking to enroll up to 100,000 men and women at various locations across the United States.

To be eligible for this study, participants must be at least 18 years old, able to understand the study information, and willing to follow the study procedures. They should also be able to provide personal health information and pay for the WB-MRI procedure upfront. However, individuals with certain medical devices, those who are pregnant, or those seeking WB-MRI instead of other necessary tests will not be able to participate. If you join the study, you can expect to receive a comprehensive WB-MRI scan, which is a painless and non-invasive imaging test that helps doctors see inside your body.

Gender

ALL

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.