MRI Scans for Preventive Healthcare

(Hercules Trial)

Overseen By Kayla MacLeod, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hercules

Disqualifiers: Pregnancy, Implanted pacemakers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100000 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

How 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. ^{2 4 5 7 8}

Research Team

Perry Kaneriya, MD, MBA

Principal Investigator

Hercules

Eligibility 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

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

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

Treatment Details

Interventions

• Whole-Body Magnetic Resonance Imaging (WB-MRI)

Trial Overview 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.

Participant Groups

Group I: MRI Scan Arm Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Hercules

Lead Sponsor

Trials

1

Recruited

100,000+

Prenuvo Inc

Collaborator

Trials

1

Recruited

100,000+

Findings from Research

Whole-body MRI (WB-MRI) screening in a study of 576 asymptomatic individuals revealed that about one-third had clinically relevant findings, leading to treatments for 11.2% of participants, including the detection of cancers and intracranial aneurysms.

Despite its effectiveness in identifying some health issues, WB-MRI has limitations in detecting certain cancers, such as colon, thyroid, and breast cancers, suggesting it should be used as a complementary screening tool rather than a standalone diagnostic method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body MRI for preventive health screening: Management strategies and clinical implications. Basar, Y., Alis, D., Tekcan Sanli, DE., et al.[2021]

Whole-body MRI (WB MRI) was evaluated in a study of 229 patients and identified two cases of malignancy among six suspicious lesions, demonstrating its potential utility in cancer screening.

In addition to detecting possible cancers, WB MRI revealed various nonmalignant conditions, such as disc issues and shoulder bursitis, indicating its effectiveness for comprehensive health evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial experience with the use of whole body MRI for cancer screening and regular health checks. Lee, SY., Park, HJ., Kim, MS., et al.[2019]

In a study of 134 cancer patients, whole body magnetic resonance imaging (WB-MRI) was well tolerated, with 85.5% of participants reporting a positive experience and 90.3% expressing willingness to undergo the procedure again.

Patients preferred WB-MRI over other imaging methods like CT and PET/CT, with 68.7% favoring WB-MRI, indicating its potential as a preferred diagnostic tool in oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient centered radiology: investigating 3 Tesla whole body MRI acceptance in cancer patients. Rossi, A., Prochowski Iamurri, A., Diano, D., et al.[2023]

Whole-body magnetic resonance imaging (WB-MRI) is a radiation-free imaging technique that can effectively detect and characterize lesions in less than 40 minutes, making it a valuable tool in cancer management.

International guidelines now recommend WB-MRI for various cancers, including multiple myeloma and prostate cancer, due to its superior ability to evaluate treatment responses and screen high-risk patients compared to traditional imaging methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging: technique, guidelines and key applications. Summers, P., Saia, G., Colombo, A., et al.[2021]

A review of 12 studies involving 6214 whole-body MRI examinations found that 95% of asymptomatic subjects had abnormal findings, but only 1.1% were histologically confirmed as cancer, indicating a high rate of benign findings.

The studies showed significant variability in methodologies and classification systems, suggesting that while WB-MRI can identify potential issues, its efficacy for cancer screening in asymptomatic individuals remains unclear, and experienced radiologists are essential for accurate interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging (WB-MRI) for cancer screening in asymptomatic subjects of the general population: review and recommendations. Zugni, F., Padhani, AR., Koh, DM., et al.[2022]

A study involving 135 cancer patients found that whole body magnetic resonance imaging (WB-MRI) is well-accepted and leads to high satisfaction levels, with 80% of participants expressing positive feelings about the procedure.

Patients who received more information prior to the WB-MRI reported higher satisfaction, indicating that effective communication from healthcare providers can enhance the acceptance of this non-radiative imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigating cancer patient acceptance of Whole Body MRI. Oliveri, S., Pricolo, P., Pizzoli, S., et al.[2019]

Whole-body magnetic resonance imaging (WB-MRI) is recommended for cancer screening in individuals with cancer predisposition syndromes, helping to improve health and survival rates in high-risk populations.

There is an increasing interest in using WB-MRI for cancer screening in asymptomatic individuals from the general population, highlighting the need for standardized acquisition protocols and tailored recommendations for different groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging (WB-MRI) for cancer screening: recommendations for use. Petralia, G., Zugni, F., Summers, PE., et al.[2022]

Recent advancements in whole-body MRI technology allow for high-resolution imaging in a single 60-minute examination, which could enhance cancer screening efforts.

The review discusses the potential benefits and challenges of using whole-body MRI, including its application in detecting common malignancies, while also addressing limitations based on current experiences and literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oncologic screening with whole-body MRI: possibilities and limitations]. Schäfer, JF., Fischmann, A., Lichy, M., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Whole-body MRI for preventive health screening: Management strategies and clinical implications. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

An initial experience with the use of whole body MRI for cancer screening and regular health checks. [2019]

3. Italy pubmed.ncbi.nlm.nih.gov

Patient centered radiology: investigating 3 Tesla whole body MRI acceptance in cancer patients. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging: technique, guidelines and key applications. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging (WB-MRI) for cancer screening in asymptomatic subjects of the general population: review and recommendations. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Investigating cancer patient acceptance of Whole Body MRI. [2019]

7. Italy pubmed.ncbi.nlm.nih.gov

Whole-body magnetic resonance imaging (WB-MRI) for cancer screening: recommendations for use. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

[Oncologic screening with whole-body MRI: possibilities and limitations]. [2019]