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Hematopoietic and Lymphoid System NeoplasmEarly Phase 1NCT05868486

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

A Early Phase 1 study testing Biospecimen Collection, Genetic Testing for Cancer Risk and Liquid Biopsy in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Biospecimen Collection, Genetic Testing for Cancer Risk and Liquid Biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
20 May 2022to 20 Sep 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

  1. 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:

  1. 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).

Being tested
Biospecimen Collection, Genetic Testing for Cancer Risk, Liquid Biopsy, Magnetic Resonance Imaging of the Whole Body without Contrast, Survey Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Genetic Testing for Cancer RiskGenetic

    Also called Cancer Risk Assessment with Genetic Testing and Counseling

    Undergo germline testing

  • Liquid BiopsyProcedure or surgery

    Also called Plasma Biopsy

    Undergo liquid biopsy testing

  • Magnetic Resonance Imaging of the Whole Body without ContrastProcedure or surgery

    Also called WB-MRI without Contrast, Whole Body Magnetic Resonance Imaging without Contrast, Whole Body MRI without Contrast, Whole-body MRI without Contrast

    Undergo whole body MRI without contrast

  • Survey AdministrationOther

    Complete surveys

Study groups in NCT05868486
Study groupRoleWhat they receive
Whole Body MRI and Liquid BiopsyExperimentalPatients undergo WBM without contrast and blood sample collection for liquid biopsy
Receives: Procedure: Biospecimen Collection; Genetic: Genetic Testing for Cancer Risk; Procedure: Liquid Biopsy; Procedure: Magnetic Resonance Imaging of the Whole Body without Contrast; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  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").

    Measured: Up to 6 months after WBM

Secondary outcomes (10)

  1. 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.

    Measured: Up to 6 months after WBM

  2. 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.

    Measured: Up to 6 months after WBM

  3. 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.

    Measured: Up to 6 months after WBM

  4. 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.

    Measured: Up to 6 months after WBM

  5. 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.

    Measured: Up to 6 months after WBM

  6. 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.

    Measured: Up to 6 months after WBM

  7. 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.

    Measured: Up to 6 months after WBM

  8. 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.

    Measured: Up to 6 months after WBM

  9. 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.

    Measured: Up to 6 months after WBM

  10. 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.

    Measured: Up to 6 months after WBM

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2023
  2. Study start20 May 2022
  3. Primary completion20 Sep 2027 (estimated)
  4. Study completion20 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05868486
Sponsor's protocol ID
21574
Other IDs
NCI-2022-01829, 21574, P30CA033572
Status last verified
Nov 2026
First submitted
29 Mar 2023
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

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.

    PubMed 39748640

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biospecimen Collection, Genetic Testing for Cancer Risk and Liquid Biopsy in people with Hematopoietic and Lymphoid System Neoplasm and Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM) (time frame: Up to 6 months after WBM). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05868486, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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