A Proof of Concept Study for [18F]FB-IL2 PET Imaging of Infiltrating T Cells After Renal Transplantation; a Diagnostic Tool for Acute Rejection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The ability of the [18F]FB-IL2 PET to detect renal transplant rejection
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The ability of the [18F]FB-IL2 PET to detect renal transplant rejection
时间窗: 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.
次要结局
- 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 and correlation with renal function(At study day 2, when PET procedure is performed.)
研究者
J.S.F. Sanders
MD, PhD
University Medical Center Groningen