Actively Recruiting
A Multi-Site Prospective, Single-Arm, Observational Study On The Accuracy Of Whole Body Magnetic Resonance Imaging Screening To Predict Clinically Significant Diagnoses In Adults Interested In Advanced Preventive Healthcare
Led by Hercules · Updated on 2025-04-30
100000
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
H
Hercules
Lead Sponsor
P
Prenuvo Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, single-arm observational study to collect data from whole-body magnetic resonance imaging (WB-MRI) scans of up to 100,000 adult participants aged 18 and older across multiple clinical sites in the United States. The study aims to evaluate the accuracy of WB-MRI screening in predicting clinically significant diseases, including cancer, metabolic diseases, aneurysms, and neurologic disorders, in people interested in proactive and advanced preventive healthcare. Participants must meet specific inclusion and exclusion criteria to ensure safety and appropriate enrollment. Participants will undergo a whole-body MRI scan as the primary procedure of the study. The study does not involve any treatment but focuses on diagnostic imaging to detect and assess clinically significant diseases. The study plans to follow participants for up to 10 years to monitor and evaluate outcomes related to clinically significant disease diagnoses and oncological findings using established scoring systems such as the ONCO-RADS score. During the study, participants will provide clinical, demographic, and medical history information and complete consent procedures. Researchers will collect and analyze data from the MRI scans and track diagnoses over the follow-up period. The study includes safety monitoring to exclude individuals with contraindicated medical devices or conditions that could pose risks. Participation involves attendance at clinical sites for imaging and data collection, with long-term follow-up to assess health outcomes over up to a decade.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years of age or older at the time of enrollment
- Be able to read and understand the study procedures
- Be willing and able to follow study procedures including proper breathing and minimizing body movement during the MRI
- Be willing and able to provide clinical, demographic, medical history, and current medication information
- Be able to pay in advance for the MRI procedure and interpretation
- Complete all required consent procedures
You will not qualify if you...
- Have implanted medical devices that are not safe for MRI (such as pacemakers, aneurysm clips, cochlear implants, drug pumps, neurostimulators, bone growth stimulators, or certain contraceptive devices)
- Be pregnant
- Seeking WB-MRI instead of other appropriate standard diagnostic imaging when such imaging is more suitable
- Be an employee of the study site or sponsor
- Have a medical condition or serious illness that could risk safety or interfere with study goals, as judged by the Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo a whole body MRI scan to detect clinically significant diagnoses.
1 visit (in-person)
Duration - Up to 10 years
Participants are followed for up to 10 years to monitor for clinically significant diseases and other relevant health outcomes.
Periodic assessments may occur during follow-up
Trial Site Locations
Total: 1 location
1
Hercules Research Center
Watertown, Massachusetts, United States, 02472
Actively Recruiting
Research Team
K
Kayla MacLeod, BS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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