IL2 Imaging in Renal Transplantation

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Diagnostic test: [18F]FB-IL2 PET scan

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]FB-IL2 PET scan; Renal transplant recipients with a clinical suspicion for renal transplant rejection.	Diagnostic test: [18F]FB-IL2 PET scan; [18F]FB-IL2 PET scan procedure

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Jan-Stephan F Sanders, MD, PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: September 22, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 6, 2017

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 201501004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No