Phase 1
N=9
Detection of Graft Versus Host Disease With [18F]F-AraG
Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT03367962 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan — 0; 2; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- [18F]F-Ara-G (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- CellSight Technologies, Inc.
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution of Acute GVHD Grades (MAGIC Criteria) at Time of PET/CT Scan |
0; 2; 0; 0; 4; 0 | — |
| PRIMARY Number of Participants Who Developed aGVHD Within 6 Months Post-Scan. |
6; 2 | — |
| SECONDARY Biodistribution and Kinetic Behavior of [18F]F-AraG in Healthy Volunteers |
— | — |
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 who require systemic therapy, and patients at high risk for developing acute GVHD. [18F]F-AraG PET scans will be compared to biopsy results to correlate T cell accumulation which is implicated in the disease. High risk patients will be followed to verify predictive potential of [18F]F-AraG.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Pregnant or nursing
- Individuals with known or suspected substance abuse, obtained by self-reporting.
- Uncontrolled infection
- Relapsed/persistent malignancy
- Currently receiving immunotherapy
Data sourced from ClinicalTrials.gov (NCT03367962). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.