Recruiting

Observational Study

Sponsor:

Inova Health Care Services

Code:

NCT06931561

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Interventions

Whole Body MRI

Whole Body Ultrasound

MCD Assay

Occupational Exposure Questionnaire

Study Details

Brief summary:

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.

Conditions

Cancer

Study ID

NCT06931561

Start date

Feb 11, 2025

Status verified date

Jun, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 35 years old
  • at least 10 cumulative years working as a firefighter
  • Actively serving as a firefighter (active or volunteer) with completion of NFPA physical examination within the past 6 months
  • Ability to understand and willing to sign informed consent
  • Ability to understand and willing to sign the Health Insurance Portability and Accountability Act (HIPAA) Authorization
  • Additional eligibility criteria in protocol

Exclusion Criteria:

  • No prior history of any invasive cancer within the previous 5 years (non-melanoma skin cancer and in situ carcinoma would still be eligible) and no current diagnostic workup for suspicion of cancer
  • Received a whole-body MRI, whole-body ultrasound, or been tested with a MCD within the past 1-year
  • For women of childbearing potential, pregnancy and no plans for pregnancy for the duration of the study
  • Additional exclusion criteria in protocol

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

active comparator: Whole Body MRI

Prenuvo whole body magnetic resonance imaging

active comparator: Whole Body Ultrasound

High frequency sound waves

Interventions

Whole Body MRI

Whole body MRI

Whole Body Ultrasound

Whole Body Ultrasound

MCD Assay

Cancer detection blood test

Occupational Exposure Questionnaire

Questionnaire

Primary outcome measure

  • Number of confirmed pre-malignancies detected with each investigational screening tool [ Time Frame: up to 1 year (± 2 months) ]
  • Number of confirmed malignancies detected with each investigational screening tool [ Time Frame: up to 1 year (± 2 months) ]

Central Contacts and Locations

Central contacts

Salman Baig

(571) 472-3500salman.baig@inova.org

Bryan Bassig, PhD

(571) 472-3500bryan.bassig@inova.org

Locations

Inova Schar Cancer - Saville Cancer Screening and Prevention Center

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Salman Baig

571-472-3500salman.baig@inova.org

Bryan Bassig, PhD

(571) 472-3500bryan.bassig@inova.org

Principal Investigator:

Rebecca Kaltman, MD

More Information

Sponsor

Inova Health Care Services

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Inova Health Care Services on 2026-06-12.