An interventional study of [18F]FB-IL2 PET scan in Kidney Transplant Rejection, sponsored by University Medical Center Groningen. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-05-11.
Sponsored by University Medical Center Groningen · Not applicable, Interventional, and Diagnostic
After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and accurate diagnosis is vital for implementation of additional immunosuppressive therapy. Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection. However, this is an intervention associated with complications like bleeding, patient discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false negative results. So, the introduction of a new non-invasive diagnostic tool for allograft rejection could have major implications for the care of renal transplant recipients. For the purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET), the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection
Exclusion Criteria:
Renal transplant recipients with a clinical suspicion for renal transplant rejection.
Diagnostic Test: [18F]FB-IL2 PET scan
\[18F\]FB-IL2 PET scan procedure
The ability of the [18F]FB-IL2 PET to detect renal transplant rejection
Uptake of \[18F\]FB-IL2 in the renal transplant will be correlated to inflammatory infiltrate and histological BANFF score.
Time frame: At study day 2, when PET procedure is performed.
Uptake of [18F]FB-IL2 and correlation with renal function
Uptake of \[18F\]FB-IL2 in the renal transplant will be correlated to renal function as measured by 24-hours urine clearance and the Modification of Diet in Renal Disease equation (MDRD).
Time frame: At study day 2, when PET procedure is performed.
Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations
Uptake of \[18F\]FB-IL2 in the renal transplant will be correlated to T-cell subpopulations in urine and blood.
Time frame: At study day 2, when PET procedure is performed.
Plan to share: Undecided
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This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen