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 Overview
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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.

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).

Official Title
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Whole Body MRI and Liquid Biopsy for Early Cancer Detection

Conditions
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Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* 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


Participation Criteria
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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 Exclusion Criteria: Unable to provide informed consent Contraindications to MRI (implants, metal, or claustrophobia that would preclude MRI)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whole Body MRI and Liquid Biopsy<br>Patients undergo WBM without contrast and blood sample collection for liquid biopsy | Procedure: Biospecimen Collection<br>* Undergo blood sample collection<br>* Other names: Specimen Collection;Genetic: Genetic Testing for Cancer Risk<br>* Undergo germline testing<br>* Other names: Cancer Risk Assessment with Genetic Testing and Counseling;Procedure: Liquid Biopsy<br>* Undergo liquid biopsy testing<br>* Other names: Plasma Biopsy;Procedure: Magnetic Resonance Imaging of the Whole Body without Contrast<br>* Undergo whole body MRI without contrast<br>* Other names: Whole-body MRI without Contrast;Other: Survey Administration<br>* Complete surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM | 
| 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. | Up to 6 months after WBM |