NCT05868486

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for early_phase_1

Timeline
6mo left

Started May 2022

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
May 2022Oct 2026

Study Start

First participant enrolled

May 20, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2026

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

4.4 years

First QC Date

March 29, 2023

Last Update Submit

December 31, 2025

Conditions

Malignant Solid NeoplasmHematopoietic and Lymphoid System Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Prevalence of WBM findings requiring additional imaging or invasive testing

    Up to 6 months after WBM

  • Psychological distress (Germline testing)A

    Up to 6 months after WBM

  • Psychological distress (Germline testing)B

    Up to 6 months after WBM

  • Psychological distress (Liquid Biopsy)A

    Up to 6 months after WBM

  • Psychological distress (Liquid Biopsy)B

    Up to 6 months after WBM

  • +5 more secondary outcomes

Other Outcomes (1)

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

    Up to 6 months after WBM

Study Arms (1)

Whole Body MRI and Liquid Biopsy

EXPERIMENTAL

Patients undergo WBM without contrast and blood sample collection for liquid biopsy

Procedure: Biospecimen CollectionGenetic: Genetic Testing for Cancer RiskProcedure: Liquid BiopsyProcedure: Magnetic Resonance Imaging of the Whole Body without ContrastOther: Survey Administration

Interventions

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Whole Body MRI and Liquid Biopsy
Genetic Testing for Cancer RiskGENETIC

Undergo germline testing

Also known as: Cancer Risk Assessment with Genetic Testing and Counseling
Whole Body MRI and Liquid Biopsy
Liquid BiopsyPROCEDURE

Undergo liquid biopsy testing

Also known as: Plasma Biopsy
Whole Body MRI and Liquid Biopsy
Magnetic Resonance Imaging of the Whole Body without ContrastPROCEDURE

Undergo whole body MRI without contrast

Also known as: WB-MRI without Contrast, Whole Body Magnetic Resonance Imaging without Contrast, Whole Body MRI without Contrast, Whole-body MRI without Contrast
Whole Body MRI and Liquid Biopsy
Survey AdministrationOTHER

Complete surveys

Whole Body MRI and Liquid Biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Related Publications (1)

  • 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.

    PMID: 39748640DERIVED

MeSH Terms

Interventions

Specimen HandlingGenetic TestingCounselingLiquid BiopsyContrast Media

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health ServicesMental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesBiopsyCytodiagnosisCytological TechniquesDiagnostic Uses of ChemicalsPharmacologic ActionsChemical Actions and UsesSpecialty Uses of Chemicals

Study Officials

  • Dan Raz

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2023

First Posted

May 22, 2023

Study Start

May 20, 2022

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

October 19, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

US(1)