IL2 Imaging in Renal Transplantation

Not Applicable

Active, not recruiting

• Conditions: Kidney Transplant Rejection
• Interventions: Diagnostic Test: [18F]FB-IL2 PET scan

• Registration Number: NCT03304223
• Lead Sponsor: University Medical Center Groningen

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-22
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-06
• Study Start: 2017-12-01
• Primary Completion: 2022-12-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-11
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]FB-IL2 PET scan	[18F]FB-IL2 PET scan	Renal transplant recipients with a clinical suspicion for renal transplant rejection.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands