Clinical trial NCT06212479: 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.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Metabolic Disease
Aneurysm
Neurologic Disorder
Lead sponsor: Hercules
Sponsor class: INDUSTRY
Collaborators: name: Prenuvo Inc
First posted: 2024-01-18
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients above 18 years of age.

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.


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.

Primary outcomes:
measure: Primary Endpoint and 5-point scale of CSD (Clinically Significant Disease) of CSD diagnosed post-baseline in general population subjects.
timeFrame: Up to 10 Years
Secondary outcomes:
measure: 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
timeFrame: Up to 10 Years
Other outcomes:
Locations:
city: Watertown
country: United States
facility: Hercules Research Center
state: Massachusetts
Study officials:
affiliation: Hercules
name: Perry Kaneriya, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: