Evaluation of Kidney Fibrosis Via FAPI PET/CT
Evaluation of Renal Renal Fibrosis Vie FAPI-PET-CT: a Prospective Non-randomized Open-label Single-center Pilot Study
Interstitial fibrosis is a hallmark of progression in chronic kidney disease (CKD), yet it can presently be assessed only by kidney biopsy, which is invasive and prone to sampling error.
In recent years the advances in molecular imaging, especially high spatial and temporal resolution of the scanners and the development of radiopharmaceuticals to visualize metabolic processes or immune cells have been significant, opening promising possibilities in multiple fields. It was demonstrated that in autoimmune diseases as Crohns disease the use of fibrosis markers, as 68Ga-FAPI tracer in PET/MRI could adequately reflect the amount of fibrosis found in histologic work up of tissue specimens in the gut. Also first data in small studies including patients with chronic kidney disease showed promising results indicating that tracer uptake could reflect the degree of fibrosis.
This study aims to investigate the utility of PET/CT imaging with a [68Ga]-DOTA.SA.FAPi tracer to reflect the degree of fibrosis found in the histological work up. We hypothesize that PET/CT findings reflect histological found fibrotic changes in kidney biopsies, potentially offering a superior alternative due to its non-invasive nature and the possibility to capture the entire organ.
研究概览
详细说明
Background More than 10% of the general population worldwide is affected by chronic kidney disease (CKD) and approximately four million people are living on renal replacement therapy. Main causes for CKD are life style factors as hypertension and diabetes. Modern therapies improve outcome and reduce disease progression and can sustain organ function by reducing fibrosis as disease progression is mostly characterized by progressive tissue remodeling, especially including fibrosis leading to GFR reduction. To quantify the degree of fibrosis an invasive procedure as the kidney biopsy is necessary.The procedure and preparation for native kidney and graft biopsies requires detailed planning as bleeding risk and consecutive consequences of bleeding potentially leading to nephrectomy have to be minimized. Nevertheless, significant complications as erythrocyte transfusions are observed in up to 1,6 % and in 0,3% invasive interventions are needed to stop bleeding following kidney biopsies. These complications occur despite optimal preparation and in significant cases a biopsy is not feasible due to vital platelet inhibition and anticoagulation or these have to be paused for several days prior to biopsy reflecting a significant time loss.
Additionally in patients with a long known CKD and comorbidities (exg. hypertension, hyperglycemia) where a rapid decrease in kidney function also with concomitant significant proteinuria can reflect the natural slope of kidney function decline and histologic biopsy work up eventually often reveals chronic lesions and extended fibrosis as cause for progressive decline in kidney function.
In these cases and due to the mentioned difficulties and significant periprocedural risk, a non-invasive tool to bona fide visualize ongoing processes or existing damage in the kidney is preferable and due to advances in imaging techniques a promising approach.
PET Imaging In recent years the advances in molecular imaging, especially high spatial and temporal resolution of the scanners and the development of radiopharmaceuticals to visualize metabolic processes or immune cells have been significant, opening promising possibilities in multiple fields.
Nowadays widely used FDG PET/CT has proven its use in clinical practice in detecting areas of high metabolism as inflammation or cancer. By the use of alternative radiopharmaceuticals, further processes like blood flow, cell proliferation or receptor distribution in organs can be quantified at the molecular level. Fibrosis evaluation using 68Ga-FAPI tracer demonstrated that in autoimmune diseases as Crohns disease the use of fibrosis markers in PET/MRI could adequately reflect the amount of fibrosis found in histologic work up of tissue specimens in the gut and small studies have already shown promising results in fibrosis evaluation in native kidneys.
Methods We aim to prospectively include 30 patients with different degrees of fibrosis in the kidney biopsy and perform a PET/CT scan using 68Ga-DOTA.SA.FAPi tracer to evaluate a correlation between tracer uptake and the histologic findings.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Constantin N Aschauer, MD
- 电话号码:004314040043910
- 邮箱:constantin.aschauer@muv.ac.at
研究联系人备份
- 姓名:Rainer Oberbauer, MD, PhD, MD, PhD
- 电话号码:004314040043900
- 邮箱:rainer.oberbauer@meduniwien.ac.at
学习地点
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State of Vienna
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Vienna、State of Vienna、奥地利、1090
- 招聘中
- General hospital Vienna
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接触:
- Constantin N Aschauer, MD
- 电话号码:004314040043910
- 邮箱:constantin.aschauer@muv.ac.at
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Histological workup of native kidney present
Exclusion Criteria:
- Age <18
- Pregnancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:FAPI PET/CT scan
All included patients will have a FAPI PET/CT scan
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Included patients will undergo one PET/CT scan with 68GA-FAPI tracer application
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Correlation of SUVmax and SUVmean with degree of fibrosis in the kidney biopsy assessed by H-score, firbotic area and intensitiy grade.
大体时间:Patients are included on behalf of the kidney biopsy result and one PET/CT scan will be performed. The statistical analysis and interpretation will be performed immediately after the PET/CT scan.
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The Spearman rank correlation coefficient will be used to quantify the associations between the renal PET parameters (SUVmean, SUVmax and SUVpeak) and the histological measures of fibrosis (H-score, fibrotic area and intensity grade).
Firbotic area: the percentage of any fibrotic area of the cortical part of the entire biopsy core by visual assessment (in 10% increments); fibrotic grade: an ordinal interstitial fibrosis intensity grade by visual assessment of distension of tubules and staining intensity (0 = ab-sent/nearly absent, I = mild, II = moderate, III = severe) - the most abundant grade was chosen.H-score (0-300) derived from fibrotic area percentages and corre-sponding severity grades (0-3).
Statistics will be performed with Rstudio.
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Patients are included on behalf of the kidney biopsy result and one PET/CT scan will be performed. The statistical analysis and interpretation will be performed immediately after the PET/CT scan.
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合作者和调查者
调查人员
- 首席研究员:Rainer Oberbauer, MD, PhD、Medical University of Vienna, Internal Medicine III, Department of Nephrology and Dialysis
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- 1363/2025
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
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