MRI Scans for Preventive Healthcare
(Hercules Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Hercules
Disqualifiers: Pregnancy, Implanted pacemakers, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It only mentions that you need to provide information about them.
What data supports the effectiveness of the treatment Whole-Body MRI for preventive healthcare?
Whole-Body MRI (WB-MRI) is effective in detecting bone and soft tissue issues, especially in cancer patients, and is recommended for managing multiple myeloma, prostate cancer, and melanoma. It is also increasingly used for cancer screening in the general population, offering a radiation-free alternative to other imaging methods.
12345Is whole-body MRI safe for preventive healthcare screening?
Whole-body MRI is considered safe for preventive healthcare screening as it does not use ionizing radiation, which is a type of radiation that can be harmful. It is used for early cancer detection and regular health checks without exposing patients to radiation.
12346How is the treatment Whole-Body MRI different from other treatments for preventive healthcare?
Whole-Body MRI is unique because it provides a comprehensive scan of the entire body without using ionizing radiation, making it safer for regular health checks and cancer screening. It can detect and evaluate lesions more effectively than traditional methods like bone scans and CT scans, and is recommended for high-risk patients and those with cancer predisposition syndromes.
24578Eligibility Criteria
This study is for adults over 18 interested in advanced preventive healthcare who can pay for their own WB-MRI scan. Participants must be able to provide medical history, follow study procedures like staying still during the MRI, and understand consent forms.Inclusion Criteria
I am 18 years old or older.
Be able to read and understand provided procedural information for the study
Be willing and able to provide required clinical, demographic, medical history, and concomitant medications information
+3 more
Exclusion Criteria
Self-certify that they are pregnant
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.
Be an employee of the study site or the sponsor
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
MRI Scan
Participants undergo whole-body MRI scans to capture data for analysis
1 visit
1 visit (in-person)
Follow-up
Participants are monitored for clinically significant diagnoses and oncological findings
Up to 10 years
Participant Groups
The trial is observing how well whole-body MRI scans can predict significant health issues such as nervous system disorders, cancer, aneurysms, neurological and metabolic diseases in a general population.
1Treatment groups
Experimental Treatment
Group I: MRI Scan ArmExperimental Treatment1 Intervention
Whole Body MRI Scan
Whole-Body Magnetic Resonance Imaging (WB-MRI) is already approved in European Union, United States for the following indications:
🇪🇺 Approved in European Union as Whole-Body MRI for:
- Multiple myeloma
- Prostate cancer
- Melanoma
- Cancer predisposition syndromes (e.g., Li-Fraumeni syndrome, Rb gene mutation, SDHx gene mutation)
🇺🇸 Approved in United States as Whole-Body MRI for:
- Multiple myeloma
- Prostate cancer
- Melanoma
- Cancer predisposition syndromes (e.g., Li-Fraumeni syndrome, Rb gene mutation, SDHx gene mutation)
- General population screening for proactive and advanced general preventive healthcare
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hercules Research CenterWatertown, MA
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Who Is Running the Clinical Trial?
HerculesLead Sponsor
Prenuvo IncCollaborator
References
Whole-body MRI for preventive health screening: Management strategies and clinical implications. [2021]To document the diagnostic yields of whole-body MRI (WB-MRI) screening for asymptomatic individuals by using a classification system that categorizes the findings by clinical relevance and provides a flowchart for further investigations, and to determine the influence of WB-MRI findings on clinical decision-making.
An initial experience with the use of whole body MRI for cancer screening and regular health checks. [2019]We evaluated the utility of whole-body MRI (WB MRI) for cancer screening and other regular health evaluations.
Patient centered radiology: investigating 3 Tesla whole body MRI acceptance in cancer patients. [2023]Whole body magnetic resonance imaging (WB-MRI) is a promising emerging imaging technology for detecting bone and soft tissue pathology, especially in the onco-hematological field. This study aims to evaluate cancer patients' experience of WB-MRI performed on a 3T scanner compared to other diagnostic total body examinations.
Whole-body magnetic resonance imaging: technique, guidelines and key applications. [2021]Whole-body magnetic resonance imaging (WB-MRI) is an imaging method without ionising radiation that can provide WB coverage with a core protocol of essential imaging contrasts in less than 40 minutes, and it can be complemented with sequences to evaluate specific body regions as needed. In many cases, WB-MRI surpasses bone scintigraphy and computed tomography in detecting and characterising lesions, evaluating their response to therapy and in screening of high-risk patients. Consequently, international guidelines now recommend the use of WB-MRI in the management of patients with multiple myeloma, prostate cancer, melanoma and individuals with certain cancer predisposition syndromes. The use of WB-MRI is also growing for metastatic breast cancer, ovarian cancer and lymphoma as well as for cancer screening amongst the general population. In light of the increasing interest from clinicians and patients in WB-MRI as a radiation-free technique for guiding the management of cancer and for cancer screening, we review its technical basis, current international guidelines for its use and key applications.
Whole-body magnetic resonance imaging (WB-MRI) for cancer screening in asymptomatic subjects of the general population: review and recommendations. [2022]The number of studies describing the use of whole-body magnetic resonance imaging (WB-MRI) for screening of malignant tumours in asymptomatic subjects is increasing. Our aim is to review the methodologies used and the results of the published studies on per patient and per lesion analysis, and to provide recommendations on the use of WB-MRI for cancer screening.
Investigating cancer patient acceptance of Whole Body MRI. [2019]Whole Body magnetic resonance imaging (WB-MRI) enables early cancer detection, without exposing the patient to ionizing radiation. Our aim was to investigate patients' acceptance of WB-MRI as a procedure for cancer staging and follow up.
Whole-body magnetic resonance imaging (WB-MRI) for cancer screening: recommendations for use. [2022]Whole-body magnetic resonance imaging (WB-MRI) is currently recommended for cancer screening in adult and paediatric subjects with cancer predisposition syndromes, representing a substantial aid for prolonging health and survival of these subjects with a high oncological risk. Additionally, the number of studies exploring the use of WB-MRI for cancer screening in asymptomatic subjects from the general population is growing. The primary aim of this review was to analyse the acquisition protocols found in the literature, in order to identify common sequences across published studies and to discuss the need of additional ones for specific populations. The secondary aim of this review was to provide a synthesis of current recommendations regarding the use of WB-MRI for cancer screening.
[Oncologic screening with whole-body MRI: possibilities and limitations]. [2019]In the last decade the interest in radiological screening examination increased among informed laymen enormously. Independent from the evidence of whole-body examinations for cancer prevention the discussion about screening must again be considered again due to the newest technical developments, since MRI of the whole-body with high spatial resolution is feasible now within one single examination. The newest system permits simultaneous connection of up to 76 coil elements and signal reception from 32 independent receiving channels. Whole-body MRI including magnetic resonance colonography (MRC) is feasible within 60 min. In this review potential investigation protocols will be presented. Potentials, challenges and limitations of whole-body MRI in the prevention of the malignancies most frequently leading to death are discussed on the basis own experiences examples and the literature.