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IL2 Imaging in Renal Transplantation

NCT03304223 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-05-11

No results posted yet for this study

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

Conditions

  • Kidney Transplant Rejection

Interventions

DIAGNOSTIC_TEST

[18F]FB-IL2 PET scan

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

Sponsors & Collaborators

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Jan-Stephan F Sanders, MD, PhD · University Medical Center Groningen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2022-12-01
Completion
2023-12-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03304223 on ClinicalTrials.gov