Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- MSOT in human kidney transplant
研究概览
简要总结
In this study, the condition of the kidney transplant in adults is to be assessed non-invasively using Multispectral Optoacoustic Tomography and Ultrasound Localization Microscopy (ULM). ULM imaging can be performed in a 2-dimensional and a 3-dimensional way (2D and 3D ULM). Therefore, "ULM" in the following texts and measures will refer to 2D and 3D ULM.
New, non-invasive markers that allow conclusions to be drawn about the condition of the transplant should reduce the need for invasive diagnostic procedures in the future.
详细描述
In this study, the condition of the kidney transplant in adults is to be assessed non-invasively using multispectral multispectral optoacoustic tomography and ultrasound localization microscopy. Associated with common diseases such as arterial hypertension, diabetes mellitus and cardiovascular diseases, chronic renal failure is now a leading cause of death worldwide.
Around 10% of adults in Germany, but children are also affected. The terminal stage of renal insufficiency is defined by a glomerular filtration rate (GFR) which is only 15% of the normal rate and the need for renal replacement therapy in the form of dialysis or transplantation.
Not only the higher quality of life, but also the mortality rate make kidney transplantation the procedure of choice whenever possible.
After successful kidney transplantation, regular monitoring and evaluation of the organ transplant is of great importance to detect a rejection reaction as early as possible.
Among other things, this is done during an extensive annual examination. Not infrequently, and especially in the case of abnormalities in the laboratory diagnosis of blood and urine, a kidney biopsy is also necessary in order to assess the condition of the transplant in the best possible way.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •kidney transplant
- •indication for biopsy set in clinical routine
- •minimum 18 years of age
- •written consent
排除标准
- •allergy against contrast agents/ SonoVue
- •tatoos in examined areas
- •contraindication against SonoVue
- •pregnant women
- •breast feeding women
研究组 & 干预措施
Patient with kidney transplant
Included are adult (> 18 years) patients with kidney transplant where the indication for a kidney biopsy has been set during clinical routine
干预措施: ULM and MSOT (Device)
结局指标
主要结局
MSOT in human kidney transplant
时间窗: Day1
Measuring MSOT signals (Signals for total/oxygenated/deoxygenated hemoglobin, lipid and collagen) in the human kidney transplant
Quantification of microvascular dynamics in the transplanted kidney
时间窗: Day1
Using Ultrasound Localization Microscopy (ULM) for the non invasive quantification of microvascular dynamics
Visualization of microvascular architecture in the transplant kidney
时间窗: Day1
Using Ultrasound Localization Microscopy (ULM) for the non invasive visualization of microvasculature
次要结局
- MSOT collagen and histology(Day1)
- ULM quantification and sonography(Day1)
- ULM visuals and histology(Day1)
- ULM quantification and histology(Day1)
- MSOT: Hb and histology(Day1)
- MSOT Lipid and sonographic results(Day1)
- MSOT lipid and histology(Day1)
- MSOT Lipid and laboratory results(Day1)
- MSOT collagen and sonography(Day1)
- MSOT collagen and laboratory results(Day1)
- ULM visuals and laboratory results(Day1)
- ULM visuals and standard sonography(Day1)
- ULM quantification and laboratory results(Day1)
- MSOT: hb and laboratory results(Day1)
- MSOT hb and sonography(Day1)
- MSOT hb and histology(Day1)
研究者
Ferdinand Knieling
Principal Investigator, Pediatric Translational Imaging Laboratory
University of Erlangen-Nürnberg Medical School
