Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography
NCT Number: NCT06472947
Acronym: ESTIMATOR
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Kidney Transplant|Kidney Biopsy
Interventions: DEVICE: ULM and MSOT
Sponsor: University of Erlangen-Nürnberg Medical School
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06-18
Completion Date: 2025-06-18
Locations: Department of Pediatrics and Adolescent Medicine, Erlangen, Bavaria, 91054, Germany

Summary:
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. 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.

Primary Outcome Measures: Visualization of microvascular architecture in the transplant kidney, Using Ultrasound Localization Microscopy (ULM) for the non invasive visualization of microvasculature, Day1|Quantification of microvascular dynamics in the transplanted kidney, Using Ultrasound Localization Microscopy (ULM) for the non invasive quantification of microvascular dynamics, Day1|MSOT in human kidney transplant, Measuring MSOT signals (Signals for total/oxygenated/deoxygenated hemoglobin, lipid and collagen) in the human kidney transplant, Day1
Secondary Outcome Measures: 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), Day1|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), Day1|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), Day1|ULM quantification and histology, ULM: Correlation of parameters of quantified microvascular perfusion dynamics in the transplant kidney with histological parameters (e.g. Banff classification), Day1|ULM quantification and laboratory results, - ULM: Correlation of parameters of the quantified microvascular perfusion dynamics in the transplant kidney with laboratory chemical parameters (including renal function parameters, inflammation parameters), Day1|MSOT: Hb and histology, MSOT: Correlation of the signal determined with MSOT for total/oxygenated/deoxygenated, Day1|MSOT: hb and laboratory results, - MSOT: Correlation of the signal for total/oxygenated/deoxygenated hemoglobin with laboratory chemical parameters, Day1|MSOT hb and sonography, - MSOT: Correlation of the signal for total/oxygenated/deoxygenated hemoglobin determined with MSOT with sonographic parameters, Day1|MSOT hb and histology, - MSOT: Correlation of the signal for total/oxygenated/deoxygenated hemoglobin with with histological parameters, Day1|MSOT Lipid and laboratory results, - MSOT: Correlation of the signal for lipid determined with MSOT with laboratory chemical parameters, Day1|MSOT Lipid and sonographic results, MSOT: Correlation of the signal for lipid determined with MSOT with sonographic parameters parameters, Day1|MSOT lipid and histology, MSOT: Correlation of the signal for lipid determined with MSOT with histological parameters, Day1|MSOT collagen and sonography, - MSOT: Correlation of the signal for collagen determined with MSOT with sonographic parameters, Day1|MSOT collagen and histology, MSOT: Correlation of the signal for collagen determined with MSOT with histological parameters, Day1|MSOT collagen and laboratory results, - MSOT: Correlation of the signal for collagen determined with MSOT with laboratory chemical parameters, Day1|ULM quantification and sonography, Correlation of parameters of the quantified microvascular perfusion dynamics in the transplant kidney with sonography in transplanted kidney, Day1