Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03304223
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-11
First Post:
2017-09-22
Brief Title:
IL2 Imaging in Renal Transplantation
Sponsor:
University Medical Center Groningen
Organization:
University Medical Center Groningen
Study Overview
Official Title:
A Proof of Concept Study for 18FFB-IL2 PET Imaging of Infiltrating T Cells After Renal Transplantation a Diagnostic Tool for Acute Rejection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 18FFB-IL2 has been developed The investigators hypothesized that a high correlation exists between 18FFB-IL2 uptake and the extend of T cell infiltration into renal transplants with signs of rejection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None