IL2 Imaging in Renal Transplantation

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EstadoReclutamiento

Patrocinadores

University Medical Center Groningen

ENSAYO CLÍNICO: NCT03304223

BioSeek: nct03304223

Palabras clave

hemorragia

Abstracto

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

fechas

Verificado por última vez:	11/30/2018
Primero enviado:	09/21/2017
Inscripción estimada enviada:	10/01/2017
Publicado por primera vez:	10/05/2017
Última actualización enviada:	01/02/2019
Última actualización publicada:	01/03/2019
Fecha de inicio real del estudio:	11/30/2017
Fecha estimada de finalización primaria:	11/30/2020
Fecha estimada de finalización del estudio:	11/30/2021

Condición o enfermedad

Kidney Transplant Rejection

Intervención / tratamiento

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

Fase

Fase 1

Grupos de brazos

Brazo	Intervención / tratamiento
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

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	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.

Salir

Medidas de resultado primarias

1. 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.

Medidas de resultado secundarias

1. 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).

2. 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.