Trials / Active Not Recruiting
Active Not RecruitingNCT05868486
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
- Status
- Active Not Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- City of Hope Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Biospecimen Collection | Undergo blood sample collection |
| GENETIC | Genetic Testing for Cancer Risk | Undergo germline testing |
| PROCEDURE | Liquid Biopsy | Undergo liquid biopsy testing |
| PROCEDURE | Magnetic Resonance Imaging of the Whole Body without Contrast | Undergo whole body MRI without contrast |
| OTHER | Survey Administration | Complete surveys |
Timeline
- Start date
- 2022-05-20
- Primary completion
- 2026-10-19
- Completion
- 2026-10-19
- First posted
- 2023-05-22
- Last updated
- 2026-01-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05868486. Inclusion in this directory is not an endorsement.