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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03367962.
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.
Lead OrganizationCellSight Technologies, Inc.
