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

Early Phase 1Active Not RecruitingNCT05868486

City of Hope Medical Center100 enrolled

Overview

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.

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

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Interventions

Biospecimen CollectionPROCEDURE

Undergo blood sample collection

Genetic Testing for Cancer RiskGENETIC

Undergo germline testing

Liquid BiopsyPROCEDURE

Undergo liquid biopsy testing

Magnetic Resonance Imaging of the Whole Body without ContrastPROCEDURE

Undergo whole body MRI without contrast

Survey AdministrationOTHER

Complete surveys

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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").