Cancer Screening for Firefighters

Overseen By Bryan Bassig, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inova Health Care Services

Disqualifiers: Invasive cancer, Recent whole-body MRI, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment MCD Assay, Whole Body MRI, Whole Body Ultrasound for cancer screening in firefighters?

The research highlights that firefighters face a higher risk of cancer due to exposure to harmful substances and lifestyle factors. Regular cancer screening, like the proposed treatments, can help detect cancer early, potentially improving survival rates. Additionally, having dedicated health and safety officers in fire departments supports the implementation of cancer screening activities, which may enhance the effectiveness of these treatments. ^{1 2 3 4 5}

Is whole-body MRI safe for cancer screening in humans?

Whole-body MRI is generally considered safe for cancer screening, and it is recommended for individuals with a high risk of cancer. It is increasingly used for screening in both clinical and direct-to-consumer settings, with studies focusing on its effectiveness and psychological impact. ^{6 7 8 9 10}

How is the treatment of Whole Body MRI and Whole Body Ultrasound for cancer screening in firefighters different from other treatments?

Whole Body MRI and Whole Body Ultrasound are unique because they provide comprehensive imaging of the entire body without using ionizing radiation, unlike other methods like PET-CT. This makes them safer for regular screening, especially in high-risk groups like firefighters, and they can detect cancer at an early stage with high accuracy. ^{6 7 11 12 13}

What is the purpose of this trial?

The purpose of this study is to further understand the clinical impact and follow-up steps that may be required based on using whole-body Magnetic Resonance Imaging (MRI) or whole-body ultrasound and blood tests to detect multiple cancers in firefighters. This study involves an investigational test (cancer blood test) that has not been approved by the U.S. Food and Drug Administration (FDA). Whole-body MRI and whole-body ultrasound are approved by the U.S. Food and Drug Administration (FDA) to be used in the diagnosis of some cancers and is approved for adults and children who present other signs of potential disease. In this study, however, the whole-body MRI and the whole-body ultrasound are considered investigational devices because they are not yet approved for use in healthy adults with no other cancer indications.

Research Team

Stephanie Van Bebber

Principal Investigator

Inova Health System - Inova Schar Cancer

Rebecca Kaltman, MD

Principal Investigator

Inova Health System - Saville Cancer Screening and Prevention Center

Eligibility Criteria

This trial is for firefighters who may be at risk of cancer due to their occupation. Participants should be healthy adults without current signs of cancer. The study aims to understand the effectiveness of whole-body MRI, ultrasound, and a new blood test in early cancer detection.

Inclusion Criteria

I am 35 years old or older.

I can understand and am willing to sign the informed consent.

Ability to understand and willing to sign the Health Insurance Portability and Accountability Act (HIPAA) Authorization

Exclusion Criteria

For women of childbearing potential, pregnancy

Additional exclusion criteria in protocol

I've had a whole-body MRI, ultrasound, or MCD test in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Blood Test

Participants undergo whole-body MRI or ultrasound and a multi-cancer detection blood test

up to 1 year

Multiple visits as needed for imaging and blood tests

Follow-up

Participants are monitored for safety and effectiveness after screening tests

up to 1 year

Follow-up visits based on test results

Treatment Details

Interventions

• MCD Assay
• Whole Body MRI
• Whole Body Ultrasound

Trial Overview The study is testing the use of an occupational exposure questionnaire, whole-body MRI scans, whole-body ultrasounds, and a novel MCD assay blood test to screen for multiple cancers in firefighters as part of a pilot program within the Inova Health System.

Participant Groups

Group I: Whole Body MRI Active Control 3 Interventions

Prenuvo whole body magnetic resonance imaging

Group II: Whole Body Ultrasound Active Control 3 Interventions

High frequency sound waves

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Virginia Department of Health

Collaborator

Trials

5

Recruited

970+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mortality and cancer incidence in a pooled cohort of US firefighters from San Francisco, Chicago and Philadelphia (1950-2009). [2021]

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

Modifiable risk factors and cancer mortality in transport, rescue, and security industries. [2022]

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

Impact of Organizational-level Factors on Cancer Screening Activities in Fire Departments: A Cross-sectional Study from the Sylvester Firefighter Cancer Initiative. [2020]

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

Cancer screening in US workers. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer and Potential Prevention with Lifestyle among Career Firefighters: A Narrative Review. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

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

7. 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]

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

Health outcomes and experiences of direct-to-consumer high-intensity screening using both whole-body magnetic resonance imaging and cardiological examination. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Preliminary observations regarding the expectations, acceptability and satisfaction of whole-body MRI in self-referring asymptomatic subjects. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Whole-body MRI and PET-CT in the management of cancer patients. [2020]

12. England pubmed.ncbi.nlm.nih.gov

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

13. England pubmed.ncbi.nlm.nih.gov

Development of a whole body magnetic resonance imaging protocol in normal dogs and canine cancer patients. [2019]