Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ULM and MSOT.
- Who it may be relevant to
- Registry conditions: Kidney Transplant, Kidney Biopsy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
As an invasive diagnostic procedure, the biopsy necessitates a stay in hospital, may result in side effects such as postoperative bleeding and represents a risk and an additional bruden for the patient.
MSOT has already been used to measure renal clearance and the biodistribution of fluorescent substances within the kidney, but new biomarkers have also been established in muscle and intestinal diseases and correlated with clinical scores. ULM has made the visualization of glomeruli, the smallest functional unit of the kidney, in living rats and humans and visualization of cerebral microvasculature in the human brain possible. In this study, the renal function in transplant patients will be evaluated as part of the annual examination and results from histology (biopsy), laboratory and ultrasound diagnostics will be correlated with data from MSOT and 2D and 3D ULM imaging.
The investigators believe that MSOT can be used to gain important molecular insights into the condition of the transplant. With ULM the investigators want to analyze the microvascular architecture within glomerular renal corpuscles and identify changes in perfusion dynamics as morphological signs for transplant evaluation.
Interventions
- Device ULM and MSOT
transplanted kidney will be examined non-invasively with ULM and MSOT
Primary outcome measures
- Visualization of microvascular architecture in the transplant kidney [Time frame: Day1]
- Quantification of microvascular dynamics in the transplanted kidney [Time frame: Day1]
- MSOT in human kidney transplant [Time frame: Day1]
Secondary outcome measures (12)
- ULM visuals and histology [Time frame: Day1]
- ULM visuals and laboratory results [Time frame: Day1]
- ULM visuals and standard sonography [Time frame: Day1]
- ULM quantification and histology [Time frame: Day1]
- ULM quantification and laboratory results [Time frame: Day1]
- MSOT: Hb and histology [Time frame: Day1]
- MSOT: hb and laboratory results [Time frame: Day1]
- MSOT hb and sonography [Time frame: Day1]
- MSOT hb and histology [Time frame: Day1]
- MSOT Lipid and laboratory results [Time frame: Day1]
- MSOT Lipid and sonographic results [Time frame: Day1]
- MSOT lipid and histology [Time frame: Day1]
Eligibility criteria
Inclusion criteria
- kidney transplant
- indication for biopsy set in clinical routine
- minimum 18 years of age
- written consent
Exclusion criteria
- allergy against contrast agents/ SonoVue
- tatoos in examined areas
- contraindication against SonoVue
- pregnant women
- breast feeding women
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Pediatrics and Adolescent Medicine — Erlangen
Identifiers
NCT: NCT06472947 · NTX_ULM_MSOT