NCT03367962

Detection of Graft Versus Host Disease With [18F]F-AraG

Detection of Graft Versus Host Disease With [18F]F-AraG, a Positron Emission Tomography Tracer for Activated T Cells

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: CellSight Technologies, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

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.

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 high risk for developing GVHD. A total of 5 healthy volunteers will undergo \[18F\]F-AraG PET scans and blood sampling to better understand \[18F\]F-AraG biodistribution and stability in the body. A total of 10 highly suspected acute GVHD patients will be scanned following biopsy taken to confirm aGVHD. The staging and grading of the disease using the Glucksberg grade and International Bone Marrow Transplant Registry Severity Index (IBMTR) at time of enrollment will be noted. Biopsy tissues of consented patients will be analyzed further for T cell involvement. A total of 15 high-risk patients (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) will be recruited. All those that consent will undergo a PET-CT scan with \[18F\]FAraG on day 4 +/- 2 days post transplant. Additionally, these patients will be scanned again between day 14-21 post transplant. Follow up on these patients will note those that go on to develop aGVHD and the clinical end point will be correlated to the scans to verify the predictive potential of the radiotracer.

Conditions

• Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	[18F]F-Ara-G	the \[18F\]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.

Timeline

• Start date: 2018-05-15
• Primary completion: 2023-06-21
• Completion: 2023-10-21
• First posted: 2017-12-11
• Last updated: 2025-12-08
• Results posted: 2025-12-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study