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

Whole Body MRI and Liquid Biopsy for Early Cancer Detection

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Genetic: Genetic Testing for Cancer Risk; Procedure: Liquid Biopsy; Procedure: Magnetic Resonance Imaging of the Whole Body without Contrast

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Whole Body MRI and Liquid Biopsy; Patients undergo WBM without contrast and blood sample collection for liquid biopsy

Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection; Biospecimen Collected; Specimen Collection; Other: Survey Administration; Complete surveys; Genetic: Genetic Testing for Cancer Risk; Undergo germline testing; Other Names: Cancer Risk Assessment with Genetic Testing and Counseling; Procedure: Liquid Biopsy; Undergo liquid biopsy testing; Other Names: Plasma Biopsy; Procedure: Magnetic Resonance Imaging of the Whole Body without Contrast; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (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").	Up to 6 months after WBM

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of WBM findings requiring additional imaging or invasive testing	Prevalence of WBM findings requiring additional imaging or invasive testing, described as a per participant percentage.	Up to 6 months after WBM
Psychological distress (Germline testing)A	The effect of germline testing on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.	Up to 6 months after WBM
Psychological distress (Germline testing)B	The effect of germline testing on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.	Up to 6 months after WBM
Psychological distress (Liquid Biopsy)A	The effect of LB on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.	Up to 6 months after WBM
Psychological distress (Liquid Biopsy)B	The effect of LB on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.	Up to 6 months after WBM
Psychological distress (WBM)A	The effect of Whole Body MRI on Psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.	Up to 6 months after WBM
Psychological distress (WBM)B	The effect of Whole Body MRI on Psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.	Up to 6 months after WBM
Health Related Quality of Life (HRQOL/Germline)	The effect of germline testing on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.	Up to 6 months after WBM
Health Related Quality of Life (HRQOL/LB)	The effect of LB on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.	Up to 6 months after WBM
Health Related Quality of Life (HRQOL/WBM)	The effect of WBM on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.	Up to 6 months after WBM

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between high-risk liquid biopsy findings and cancer detected on 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.	Up to 6 months after WBM

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Dan Raz, City of Hope Medical Center

Publications and helpful links

General Publications

• Raz DJ, Nehoray B, Ceniceros A, Motarjem P, Landau S, Nelson RA, Gray SW. Feasibility of a cancer screening program using multicancer early detection testing and whole-body magnetic resonance imaging in a high-risk population. Cancer. 2025 Jan 1;131(1):e35709. doi: 10.1002/cncr.35709.

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): October 19, 2026

Study Registration Dates

• First Submitted: March 29, 2023
• First Submitted That Met QC Criteria: May 19, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques; Biopsy; Cytodiagnosis; Pharmacologic Actions; Chemical Actions and Uses; Health Services; Health Care Facilities Workforce and Services; Community Health Services; Preventive Health Services; Behavioral Disciplines and Activities; Specialty Uses of Chemicals; Mental Health Services; Genetic Techniques; Genetic Services; Diagnostic Services; Diagnostic Uses of Chemicals; Liquid Biopsy; Specimen Handling; Genetic Testing; Counseling; Contrast Media
• Other Study ID Numbers: 21574 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2022-01829 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes