IL2 Imaging in Renal Transplantation

Study Overview
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Brief Summary
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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

Official Title
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A Proof of Concept Study for [18F]FB-IL2 PET Imaging of Infiltrating T Cells After Renal Transplantation; a Diagnostic Tool for Acute Rejection

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Diagnostic Test: [18F]FB-IL2 PET scan


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]FB-IL2 PET scan<br>Renal transplant recipients with a clinical suspicion for renal transplant rejection. | Diagnostic Test: [18F]FB-IL2 PET scan<br>* [18F]FB-IL2 PET scan procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At study day 2, when PET procedure is performed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | At study day 2, when PET procedure is performed. |