About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
kidney transplant
indication for biopsy set in clinical routine
minimum 18 years of age
written consent
Disqualifiers
allergy against contrast agents/ SonoVue
tatoos in examined areas
contraindication against SonoVue
pregnant women
Trial population
10 patients with kidney transplant and indication for kidney biopsy
Trial design
Cohort
Prospective
Treatments tested in this trial
ULM and MSOT
Devicetransplanted kidney will be examined non-invasively with ULM and MSOT
Treatment groups
Trial outcomes
Primary outcomes
Visualization of microvascular architecture in the transplant kidney
Using Ultrasound Localization Microscopy (ULM) for the non invasive visualization of microvasculature
Quantification of microvascular dynamics in the transplanted kidney
Using Ultrasound Localization Microscopy (ULM) for the non invasive quantification of microvascular dynamics
MSOT in human kidney transplant
Measuring MSOT signals (Signals for total/oxygenated/deoxygenated hemoglobin, lipid and collagen) in the human kidney transplant
Secondary outcomes
ULM visuals and histology
ULM: Correlation of the vascular architecture of the transplant kidney visualized by ULM (e.g. number of segmented glomeruli) with histological parameters (e.g. Banff classification)
ULM visuals and laboratory results
\- ULM: Correlation of the vascular architecture of the transplant kidney visualized by ULM (e.g. number of segmented glomeruli) with laboratory chemical parameters (e.g. renal function parameters, inflammation parameters, immunological parameters)
ULM visuals and standard sonography
\- ULM: Correlation of the vascular architecture of the transplant kidney visualized by ULM (e.g. number of segmented glomeruli) with sonographic parameters (e.g. resistance index (RI), flow velocity)
ULM quantification and histology
ULM: Correlation of parameters of quantified microvascular perfusion dynamics in the transplant kidney with histological parameters (e.g. Banff classification)
Sponsors and contacts
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