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.
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;
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;
All the patients above 18 years of age.
Case-only
Prospective
MRI Scan
Diagnostic testWhole Body MRI Scan
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.
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.
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Hercules
Lead sponsor
Prenuvo Inc
Collaborator
