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Trial Title:
Analysis of Whole Body Magnetic Resonance Imaging and Liquid Biopsy for Early Detection of Cancer in Patients With a Strong Family History of Cancer
NCT ID:
NCT05868486
Condition:
Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Whole Body MRI and Liquid Biopsy
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Genetic
Intervention name:
Genetic Testing for Cancer Risk
Description:
Undergo germline testing
Arm group label:
Whole Body MRI and Liquid Biopsy
Other name:
Cancer Risk Assessment with Genetic Testing and Counseling
Intervention type:
Procedure
Intervention name:
Liquid Biopsy
Description:
Undergo liquid biopsy testing
Arm group label:
Whole Body MRI and Liquid Biopsy
Other name:
Plasma Biopsy
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging of the Whole Body without Contrast
Description:
Undergo whole body MRI without contrast
Arm group label:
Whole Body MRI and Liquid Biopsy
Other name:
WB-MRI without Contrast
Other name:
Whole Body Magnetic Resonance Imaging without Contrast
Other name:
Whole Body MRI without Contrast
Other name:
Whole-body MRI without Contrast
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete surveys
Arm group label:
Whole Body MRI and Liquid Biopsy
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).
Criteria for 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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
City of Hope Medical Center
Address:
City:
Duarte
Zip:
91010
Country:
United States
Start date:
May 20, 2022
Completion date:
December 20, 2024
Lead sponsor:
Agency:
City of Hope Medical Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
City of Hope Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05868486
