Clinical trial NCT05868486: Analysis of Whole Body Magnetic Resonance Imaging and Liquid Biopsy for Early Detection of Cancer in Patients With a Strong Family History of Cancer
Official title: Whole Body MRI and Liquid Biopsy for Early Cancer Detection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-05-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Acceptability of germline testing, liquid biopsy and whole body magnetic resonance imaging (WBM)
timeFrame: Up to 6 months after WBM
Secondary outcomes:
measure: Prevalence of WBM findings requiring additional imaging or invasive testing
timeFrame: Up to 6 months after WBM
measure: Psychological distress (Germline testing)A
timeFrame: Up to 6 months after WBM
measure: Psychological distress (Germline testing)B
timeFrame: Up to 6 months after WBM
measure: Psychological distress (Liquid Biopsy)A
timeFrame: Up to 6 months after WBM
measure: Psychological distress (Liquid Biopsy)B
timeFrame: Up to 6 months after WBM
measure: Psychological distress (WBM)A
timeFrame: Up to 6 months after WBM
measure: Psychological distress (WBM)B
timeFrame: Up to 6 months after WBM
measure: Health Related Quality of Life (HRQOL/Germline)
timeFrame: Up to 6 months after WBM
measure: Health Related Quality of Life (HRQOL/LB)
timeFrame: Up to 6 months after WBM
measure: Health Related Quality of Life (HRQOL/WBM)
timeFrame: Up to 6 months after WBM
Other outcomes:
measure: Correlation between high-risk liquid biopsy findings and cancer detected on WBM
timeFrame: Up to 6 months after WBM
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
Study officials:
affiliation: City of Hope Medical Center
name: Dan Raz
role: PRINCIPAL_INVESTIGATOR
References: