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

Biospecimen Collection

Genetic Testing for Cancer Risk

Liquid Biopsy

Magnetic Resonance Imaging of the Whole Body without Contrast

Survey Administration

Dan Raz

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).

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

Liquid biopsy (LB) test sensitivity and specificity calculated by comparing the LB results with the WBM results, with WBM results considered the gold standard. Confusion matrix statistics, such as positive predictive value, negative predictive value, and test accuracy examined. Results reported with their corresponding 95% confidence intervals.

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").

Prevalence of WBM findings requiring additional imaging or invasive testing, described as a per participant percentage.

The effect of germline testing on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.

The effect of germline testing on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.

The effect of LB on psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.

The effect of LB on psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.

The effect of Whole Body MRI on Psychological distress, as measured by STAI survey composite score between baseline and 6 months after testing.

The effect of Whole Body MRI on Psychological distress, as measured by cancer worry scale survey scores between baseline and 6 months after testing.

The effect of germline testing on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.

The effect of LB on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.

The effect of WBM on HRQOL, as measured by the change in SF12 survey composite score between baseline and 6 months after testing.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Analysis of Whole Body Magnetic Resonance Imaging and Liquid Biopsy for Early Detection of Cancer in Patients With a Strong Family History of Cancer	NCT05868486	Hematopoietic a... Malignant Solid...	Biospecimen Col... Genetic Testing... Liquid Biopsy Magnetic Resona... Survey Administ...	18 Years -	City of Hope Medical Center
Analysis of Whole Body Magnetic Resonance Imaging and Liquid Biopsy for Early Detection of Cancer in Patients With a Strong Family History of Cancer	NCT05868486	Hematopoietic a... Malignant Solid...	Biospecimen Col... Genetic Testing... Liquid Biopsy Magnetic Resona... Survey Administ...	18 Years -	City of Hope Medical Center

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