Kidney Transplant Rejection
Conditions
Brief summary
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
Interventions
DIAGNOSTIC_TEST[18F]FB-IL2 PET scan
\[18F\]FB-IL2 PET scan procedure
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Female or male aged between 18 and 80 years. * Renal Transplant recipients * The patient understands the purpose and risks of the study and has given written informed consent to participate in the study. * All patients will have a clinical indication for renal biopsy.
Exclusion criteria
* Patients with multiple-organ transplants. * Female patients who are pregnant or unwilling to use adequate contraception during the study. * Claustrophobia * Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * A clinical reason for an immediate start of a therapeutic intervention with immunosuppressive medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The ability of the [18F]FB-IL2 PET to detect renal transplant rejection | At study day 2, when PET procedure is performed. | Uptake of \[18F\]FB-IL2 in the renal transplant will be correlated to inflammatory infiltrate and histological BANFF score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of [18F]FB-IL2 and correlation with renal function | At study day 2, when PET procedure is performed. | 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). |
| Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations | At study day 2, when PET procedure is performed. | Uptake of \[18F\]FB-IL2 in the renal transplant will be correlated to T-cell subpopulations in urine and blood. |
Countries
Netherlands
Outcome results
None listed