Help drive the systemic change from reactive to proactive healthcare

This study aims to assess the accuracy of whole body MRI (WB-MRI) screening in predicting clinically significant diagnoses in the general population.

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Study Overview

This study incorporates a single primary objective, multiple exploratory objectives, and a safety objective.

Primary Objective

The primary objective of the study is to determine the performance of WB-MRI in prediction of CSD (Clinically Significant Diagnoses) diagnosed post-baseline in general population subjects.

Safety Objective

Safety will be determined by a collection of adverse event (AE), serious adverse event (SAE), and unanticipated device effects (UADE) data.

Study Population

The study population comprises of up to 100,000 male and female subjects aged 18 and older visiting the study sites for elective screening or responding to advertisement or HCP referrals. Any subject who meets the study entry criteria is able to participate in the study. Consent forms will be given to subjects by recruiting personnel.

Inclusion Criteria

Each subject MUST:

Be over the age of 18 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 WB-MRI acquisition procedure and interpretation;

Complete all required consent procedures.

Exclusion Criteria

Each subject MUST NOT:

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.

Pricing

The study will be participant-funded and as such subjects will pay a charge in order to reimburse the sponsor for study-related costs. Costs will include recruiting, administration, licensing, technology-related, support, quality-control, radiology, medical and other costs. At present, the per-person cost is USD $2200.

For qualifying participants that may require financial assistance, several options may be available. For general participants preferring partial payments that can be broken up over a longer period of time, we have secured easy to use third-party financing services through Affirm to facilitate this option. For a subset of participants that satisfy additional health-equity based criteria, there are additional partial or complete cost subsidization options as well. To learn more about financial assistance options, contact hello@herculesstudy.org.

Enrollment

To enroll in this research study at the Hercules Research Center located at 118 Arsenal Yards Blvd. Watertown, MA 02472, please click the link below to complete the booking process and a member of our study recruiting team will be in touch.

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Frequently asked questions

How is this different to a Prenuvo scan at another location?

Clinically, the screening you will have at Hercules Research Center is similar to that ‌you would have at any other Prenuvo clinic - from the clinical examination down to the in-clinic experience.

Why are you running a clinical research study in Boston?

The study is designed to examine the long-term effectiveness of the screening Prenuvo performs in its clinics. The outcome of the study may be an important input to such screenings one day becoming standard of care for all.

What else should I know about the research study?

You will be asked to participate in a follow-up call 12-18 months after the scan so that we can check in on you, learn what resulted from the findings we made, and see if any other health problems came up in the meantime.

If I am participating in the research study, is my participation and results confidential?

A: We care a lot about your privacy. Your information is de-identified and used in aggregate form to help further the science of whole body screening and deepen our understanding of human health. More information is available in our patient consent form, which can be viewed here.

Are there other options available if I cannot afford the full study participation fee up front on my own?

There is a standard third-party option through Affirm that enables financing for partial monthly payments over time. Additionally, in certain cases of financial need where participants satisfy defined health-equity criteria for the study, there is study funding available to further subsidize the cost of participating; if you think you may qualify, please contact the Hercules research team directly for further details at hello@herculesstudy.org.

For more about information about the Prenuvo scan and services, visit the general FAQ.