To investigate if [18F]FB-IL2 PET/CT is able to detect acute allograft rejection in kidney transplantation patients.
ID
Source
Brief title
Condition
- Renal and urinary tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to
inflammatory infiltrate and histological BANFF score.
Secondary outcome
Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to renal
function as measured by 24-hours urine clearance and MDRD.
Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to T-cell
subpopulations in urine and blood.
Uptake of [18F]FB-IL2 in the transplanted kidney will be correlated to outcome
after kSORT analysis in blood.
Background summary
After renal transplantation 10 to 15% of patients experience allograft
rejection. Rapid and accurate diagnosis is vital for implementation of
additional immunosuppressive therapy and optimal outcome of renal function.
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 potential
application of a new diagnostic tool for allograft rejection would have big
added value for both clinical practice and patient comfort. For the purpose of
visualizing infiltrating T lymphocytes, this [18F]FB-IL2 PET tracer has been
developed. We 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. The value of the [18F]FB-IL2 PET is already tested in animal
models and no adverse events occurred during an ongoing human trial focusing on
the response to treatment in patients with melanomas.
Study objective
To investigate if [18F]FB-IL2 PET/CT is able to detect acute allograft
rejection in kidney transplantation patients.
Study design
This study is a feasibility study for the application of [18F]FB-IL2 PET in
kidney graft recipients. It will be conducted in a cohort of 20 patients and
will be conducted in a single center. All patients will be treated with
immunosuppressive therapy according to standard practice. The main intervention
is a [18F]FB-IL2 PET-CT scan.
Time Schedule:
Day 0: Clinical suspicion of rejection or inclusion of non-basiliximab
patient.
Day 1: Renal biopsy in case of suspicion of rejection
Day 2: Renal biopsy results + [18F]FB-IL2 PET-CT
Study burden and risks
Renal biopsy will be performed with clinical indication and will therefore not
cause additional burden for the included patients. The investigational product,
[18F]FB-IL2, is chemically almost identical to the drug Proleukin. Since it
will be used in a sub-therapeutic dose of 50 µg or less, no drug interactions
or adverse events are to be expected. Subjects in the study will undergo one
PET-CT scan, which is estimated to carry an added radiation burden of 5.9 mSv.
This total radiation burden is substantial, but considered justified by the
possibility of finding a non-invasive biomarker for the diagnosis of allograft
rejection.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
• Female or male aged between 18 and 80 years.
• 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.
• 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL62167.042.17 |