IL2 Imaging in Renal Transplantation

NCT03304223 | Unknown

• 1 other identifier: 201501004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 (\[18F\]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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Uptake of [18F]FB-IL2 and correlation with renal function

  At study day 2, when PET procedure is performed.

• Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations

  At study day 2, when PET procedure is performed.

Study Arms (1)

[18F]FB-IL2 PET scan

EXPERIMENTAL

Renal transplant recipients with a clinical suspicion for renal transplant rejection.

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

Interventions

[18F]FB-IL2 PET scan DIAGNOSTIC_TEST

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

[18F]FB-IL2 PET scan

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

Study Officials

• Jan-Stephan F Sanders, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 22, 2017
• First Posted: October 6, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

NL (1)