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

Malignant Solid Neoplasm Clinical Trial

Official title:

Whole Body MRI and Liquid Biopsy for Early Cancer Detection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05868486
• Other study ID #: 21574
• Secondary ID: NCI-2022-0182921
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: May 20, 2022
• Est. completion date: July 20, 2024

Study information

• Verified date: March 2024
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 20, 2024
• Est. primary completion date: July 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo blood sample collection

Genetic:
• Genetic Testing for Cancer Risk
Undergo germline testing

Procedure:
• Liquid Biopsy
Undergo liquid biopsy testing
• Magnetic Resonance Imaging of the Whole Body without Contrast
Undergo whole body MRI without contrast

Other:
• Survey Administration
Complete surveys

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between high-risk liquid biopsy findings and cancer detected on WBM	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.	Up to 6 months after WBM
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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