NCT03304223

IL2 Imaging in Renal Transplantation

Status unknown NA Last updated 11 May 2023

What this trial tests

NA trial testing [18F]FB-IL2 PET scan in Kidney Transplant Rejection in 20 participants. Status unknown.

Timeline

1 December 2017

Primary endpoint
1 December 2022

1 December 2023

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	1 December 2017
Primary completion	1 December 2022
Estimated completion	1 December 2023
Sites	1 location across Netherlands

Drugs / interventions tested

• [18F]FB-IL2 PET scan

Conditions studied

• Kidney Transplant Rejection — all drugs for Kidney Transplant Rejection →

Sponsor

University Medical Center Groningen

Who can join

Adults 18 to 80, any sex, with Kidney Transplant Rejection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Noninvasive Imaging of Cancer Immunotherapy.
   Abousaway O, Rakhshandehroo T, Van den Abbeele AD, Kircher MF, et al · · 2021 · cited 27× · PMID 33391977 · DOI 10.7150/ntno.50860
2. Molecular Immune Targeted Imaging of Tumor Microenvironment.
   Rakhshandehroo T, Smith BR, Glockner HJ, Rashidian M, et al · · 2022 · cited 19× · PMID 35223381 · DOI 10.7150/ntno.66556
3. An Improved Synthesis of N-(4-[¹⁸F]Fluorobenzoyl)-Interleukin-2 for the Preclinical PET Imaging of Tumour-Infiltrating T-cells in CT26 and MC38 Colon Cancer Models.
   Khanapur S, Yong FF, Hartimath SV, Jiang L, et al · · 2021 · cited 5× · PMID 33808813 · DOI 10.3390/molecules26061728