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临床试验/NCT06472947
NCT06472947招募中不适用

Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography

University of Erlangen-Nürnberg Medical School1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年6月18日最近更新:
适应症
干预措施

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

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

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferdinand Knieling

Principal Investigator, Pediatric Translational Imaging Laboratory

University of Erlangen-Nürnberg Medical School

研究点 (1)

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