Status:
COMPLETED
Detection of Graft Versus Host Disease With [18F]F-AraG
Lead Sponsor:
CellSight Technologies, Inc.
Collaborating Sponsors:
Stanford University
National Cancer Institute (NCI)
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief Summary
This is a single-center imaging study to determine utility of in vivo imaging with \[18F\]F-AraG to identify sites of Graft Versus Host Disease (GVHD) in patients highly suspected of having acute GVHD...
Detailed Description
This single-center imaging study will enroll three cohorts of participants: healthy volunteers, patients highly suspected to have acute GVHD (aGVHD) and requiring systemic therapy, and patients at hig...
Eligibility Criteria
Inclusion
- Must be 21 years of age or older.
- Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.
- For patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis.
- For patients at high risk for developing aGVHD, informed consent should be signed prior to transplant.
- For healthy volunteers only: Must have no known medical problems that would make undergoing the scan hazardous to the health of the patient or interfere with the results. In particular subjects should not have any cardiac or immunological disorders as these would likely affect the scan results. Subjects should have had a full physical exam within 6 months of the study. If healthy volunteers have not had a full medical exam within 6 months of the study, one of the nuclear medicine physicians will conduct the medical exam prior to any study procedures.
- For patients highly suspected to have aGVHD and requiring systemic therapy only: Taking steroid treatment for suspected aGVHD for 3 days or less.
- For patients at high risk for developing aGVHD only: Recipients of myeloablative or reduced intensity allogeneic transplants using either bone marrow or peripheral blood stem cells from HLA-matched or HLA-mismatched related or unrelated donors (protocols 9142, 9022, 9924) who have not yet been placed on any therapy for acute GVHD.
Exclusion
- Pregnant or nursing
- Individuals with known or suspected substance abuse, obtained by self-reporting.
- Uncontrolled infection
- Relapsed/persistent malignancy
- Currently receiving immunotherapy
Key Trial Info
Start Date :
May 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 21 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03367962
Start Date
May 15 2018
End Date
October 21 2023
Last Update
December 8 2025
Active Locations (1)
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1
Stanford Hospital
Stanford, California, United States, 94305