IL2 Imaging in Renal Transplantation

Kidney Transplant Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03304223
• Other study ID #: 201501004
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2023

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

Diagnostic Test:
• [18F]FB-IL2 PET scan
[18F]FB-IL2 PET scan procedure

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.