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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-20

Study Completion Date

2026-10-19

Brief Summary

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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.

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Detailed Description

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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

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Hematopoietic and Lymphoid System Neoplasm Malignant Solid Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Whole Body MRI and Liquid Biopsy

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

Group Type EXPERIMENTAL

Biospecimen Collection

Intervention Type PROCEDURE

Undergo blood sample collection

Genetic Testing for Cancer Risk

Intervention Type GENETIC

Undergo germline testing

Liquid Biopsy

Intervention Type PROCEDURE

Undergo liquid biopsy testing

Magnetic Resonance Imaging of the Whole Body without Contrast

Intervention Type PROCEDURE

Undergo whole body MRI without contrast

Survey Administration

Intervention Type OTHER

Complete surveys

Interventions

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Biospecimen Collection

Undergo blood sample collection

Intervention Type PROCEDURE

Genetic Testing for Cancer Risk

Undergo germline testing

Intervention Type GENETIC

Liquid Biopsy

Undergo liquid biopsy testing

Intervention Type PROCEDURE

Magnetic Resonance Imaging of the Whole Body without Contrast

Undergo whole body MRI without contrast

Intervention Type PROCEDURE

Survey Administration

Complete surveys

Intervention Type OTHER

Other Intervention Names

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Biological Sample Collection Biospecimen Collected Specimen Collection Cancer Risk Assessment with Genetic Testing and Counseling Plasma Biopsy WB-MRI without Contrast Whole Body Magnetic Resonance Imaging without Contrast Whole Body MRI without Contrast Whole-body MRI without Contrast

Eligibility Criteria

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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