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NCT Number: NCT05868486

Analysis of Whole Body Magnetic Resonance Imaging and Liquid Biopsy for Early Detection of Cancer in Patients With a Strong Family History of Cancer

This study evaluates patient acceptability of whole body magnetic resonance imaging (WBM) and liquid biopsies (LB) in detecting early stage cancer in patients with a strong family history of cancer. Collecting family history and testing for genes passed on from parent to child (germline testing) can be used to predict the likelihood of a patient developing cancer. Currently, detection of early cancers focuses on screening specific organ systems such as breast and colon cancer. Magnetic resonance imaging (MRI) uses a large magnet and radio waves to look at organs and structures inside the body. Health care professionals use MRI scans to diagnose a variety of conditions, from torn ligaments to cancer. Liquid biopsy is test that analyzes blood samples to determine if cancer cells are present. This study may help researchers determine the feasibility of WBM and liquid biopsies to detect early stage cancer in patients that have a strong family history of cancer.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

About this study

PRIMARY OBJECTIVE:

I. To assess the acceptability of the approach of LB and WBM.

SECONDARY OBJECTIVES:

I. Determine the prevalence of WBM findings requiring additional imaging or invasive testing.

II. Determine the effect of germline testing, LB, and WBM on psychological distress and health-related quality of life (HR-QOL) at 6 months after testing compared with baseline.

EXPLORATORY OBJECTIVE:

I. Determine correlation between high-risk LB findings and cancer detected on WBM.

OUTLINE: This is an observational study.

Patients undergo WBM without contrast, blood sample collection for liquid biopsy, and complete surveys on study. Germline testing may also be performed on blood sample collected as standard of care or using the Precision Medicine protocol (Institutional Review Board [IRB] 96144).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age >= 50 years, or age within 10 years of first degree relative with cancer at age of diagnosis (as long as age is >= 18)
  • Have a strong family history of cancer ( >= 2 first-degree relatives with cancer, one first and second degree relative with cancer in one lineage (side of family), or at least three first or second degree relatives with cancer in one lineage (side of the family). Non-melanoma skin cancer excluded from family history eligibility
  • Have a family history of early-onset cancer (age >40) in at least one first-degree relative
  • Willing to have 50 mL of blood (approximately 3.5 tablespoons) drawn (40 ml if germline testing already performed)
  • Able to undergo MRI (no implants, metal, or claustrophobia that would preclude MRI)
  • Any cancer diagnosis within past 5 years, excluding non-melanoma skin cancer
  • Positron emission tomography/computed tomography (PET/CT) or other whole body imaging modality (including combination of CT chest and abdomen) within 3 years
  • No signs/symptoms of possible cancer (e.g. hemoptysis, breast mass, blood per rectum, unexplained weight loss)
  • Willing to undergo standard of care genetic counseling and germline testing, or has already undergone genetic counseling and germline testing
  • Documented informed consent of the participant

Exclusion criteria

  • Unable to provide informed consent
  • Contraindications to MRI (implants, metal, or claustrophobia that would preclude MRI)

Treatment and study plan

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Genetic Testing for Cancer Risk

Genetic

Undergo germline testing

Other names: Cancer Risk Assessment with Genetic Testing and Counseling

Liquid Biopsy

Procedure

Undergo liquid biopsy testing

Other names: Plasma Biopsy

Magnetic Resonance Imaging of the Whole Body without Contrast

Procedure

Undergo whole body MRI without contrast

Other names: WB-MRI without Contrast, Whole Body Magnetic Resonance Imaging without Contrast, Whole Body MRI without Contrast, Whole-body MRI without Contrast

Survey Administration

Other

Complete surveys

Primary outcomes

  1. Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM)

    Time frame: Up to 6 months after WBM

    Acceptability, as measured by the survey question "How satisfied are you with the research study overall?" and is defined as a score of 4 ("moderately acceptable) or 5 ("highly acceptable").

Secondary outcomes

  1. Prevalence of WBM findings requiring additional imaging or invasive testing

    Time frame: Up to 6 months after WBM

    Prevalence of WBM findings requiring additional imaging or invasive testing, described as a per participant percentage.

  2. Psychological distress (Germline testing)A

    Time frame: Up to 6 months after WBM

    The effect of germline testing on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.

  3. Psychological distress (Germline testing)B

    Time frame: Up to 6 months after WBM

    The effect of germline testing on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.

  4. Psychological distress (Liquid Biopsy)A

    Time frame: Up to 6 months after WBM

    The effect of LB on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.

  5. Psychological distress (Liquid Biopsy)B

    Time frame: Up to 6 months after WBM

    The effect of LB on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.

  6. Psychological distress (WBM)A

    Time frame: Up to 6 months after WBM

    The effect of Whole Body MRI on Psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.

  7. Psychological distress (WBM)B

    Time frame: Up to 6 months after WBM

    The effect of Whole Body MRI on Psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.

  8. Health Related Quality of Life (HRQOL/Germline)

    Time frame: Up to 6 months after WBM

    The effect of germline testing on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.

  9. Health Related Quality of Life (HRQOL/LB)

    Time frame: Up to 6 months after WBM

    The effect of LB on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.

  10. Health Related Quality of Life (HRQOL/WBM)

    Time frame: Up to 6 months after WBM

    The effect of WBM on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.

Other outcomes

  1. Correlation between high-risk liquid biopsy findings and cancer detected on WBM

    Time frame: Up to 6 months after WBM

    Liquid biopsy (LB) test sensitivity and specificity calculated by comparing the LB results with the WBM results, with WBM results considered the gold standard. Confusion matrix statistics, such as positive predictive value, negative predictive value, and test accuracy examined. Results reported with their corresponding 95% confidence intervals.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Whole Body MRI and Liquid Biopsy for Early Cancer Detection

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 22, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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