IL2 Imaging in Renal Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2023-12-01

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

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Detailed Description

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Conditions

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Kidney Transplant Rejection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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[18F]FB-IL2 PET scan

Renal transplant recipients with a clinical suspicion for renal transplant rejection.

Group Type EXPERIMENTAL

[18F]FB-IL2 PET scan

Intervention Type DIAGNOSTIC_TEST

\[18F\]FB-IL2 PET scan procedure

Interventions

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[18F]FB-IL2 PET scan

\[18F\]FB-IL2 PET scan procedure

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No