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| Name | Class |
|---|---|
| Prenuvo Inc | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI Scan Arm | Whole Body MRI Scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI Scan | Diagnostic Test | Whole Body MRI Scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Each subject MUST:
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.;
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All the patients above 18 years of age.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayla MacLeod, BS | Contact | (301) 450-4451 | kayla.macleod@herculesstudy.org |
| Name | Affiliation | Role |
|---|---|---|
| Perry Kaneriya, MD, MBA | Hercules | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hercules Research Center | Recruiting | Watertown | Massachusetts | 02472 | United States |
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| Up to 10 Years |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D008659 | Metabolic Diseases |
| D000783 | Aneurysm |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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