Non-invasive Evaluation of Graft Condition in Adult Patients With Kidney Transplant Using Ultrasound Localization Microscopy and Multispectral Optoacoustic Tomography
NCT ID: NCT06472947
Last Updated: 2024-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2024-06-18
2025-06-18
Brief Summary
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Detailed Description
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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 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
ULM and MSOT
transplanted kidney will be examined non-invasively with ULM and MSOT
Interventions
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ULM and MSOT
transplanted kidney will be examined non-invasively with ULM and MSOT
Eligibility Criteria
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Inclusion Criteria
* indication for biopsy set in clinical routine
* minimum 18 years of age
* written consent
Exclusion Criteria
* tatoos in examined areas
* contraindication against SonoVue
* pregnant women
* breast feeding women
18 Years
ALL
No
Sponsors
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University of Erlangen-Nürnberg Medical School
OTHER
Responsible Party
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Ferdinand Knieling
Principal Investigator, Pediatric Translational Imaging Laboratory
Principal Investigators
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Ferdinand Knieling, PD Dr. Dr.
Role: PRINCIPAL_INVESTIGATOR
FAU Erlangen-Nuremberg
Locations
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Department of Pediatrics and Adolescent Medicine
Erlangen, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NTX_ULM_MSOT
Identifier Type: -
Identifier Source: org_study_id
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