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NCT Number: NCT06472947

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Pediatrics and Adolescent Medicine

Erlangen, Bavaria, 91054, Germany

Location status: Recruiting

Location contact

Adrian Regensburger, MD

CONTACT

[email protected]

+49 9131 8533118

Adrian Regensburger, MD

PRINCIPAL_INVESTIGATOR

Ferdinand Knieling, MD

CONTACT

[email protected]

0913185 33118

Ferdinand Knieling, MD

PRINCIPAL_INVESTIGATOR

Henriette H Mandelbaum, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ULM and MSOT

Device

transplanted kidney will be examined non-invasively with ULM and MSOT

Primary outcomes

  1. Visualization of microvascular architecture in the transplant kidney

    Time frame: Day1

    Using Ultrasound Localization Microscopy (ULM) for the non invasive visualization of microvasculature

  2. Quantification of microvascular dynamics in the transplanted kidney

    Time frame: Day1

    Using Ultrasound Localization Microscopy (ULM) for the non invasive quantification of microvascular dynamics

  3. MSOT in human kidney transplant

    Time frame: Day1

    Measuring MSOT signals (Signals for total/oxygenated/deoxygenated hemoglobin, lipid and collagen) in the human kidney transplant

Secondary outcomes

  1. ULM visuals and histology

    Time frame: Day1

    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)

  2. ULM visuals and laboratory results

    Time frame: Day1

    • 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)
  3. ULM visuals and standard sonography

    Time frame: Day1

    • 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)
  4. ULM quantification and histology

    Time frame: Day1

    ULM: Correlation of parameters of quantified microvascular perfusion dynamics in the transplant kidney with histological parameters (e.g. Banff classification)

  5. ULM quantification and laboratory results

    Time frame: Day1

    • ULM: Correlation of parameters of the quantified microvascular perfusion dynamics in the transplant kidney with laboratory chemical parameters (including renal function parameters, inflammation parameters)
  6. MSOT: Hb and histology

    Time frame: Day1

    MSOT: Correlation of the signal determined with MSOT for total/oxygenated/deoxygenated

  7. MSOT: hb and laboratory results

    Time frame: Day1

    • MSOT: Correlation of the signal for total/oxygenated/deoxygenated hemoglobin with laboratory chemical parameters
  8. MSOT hb and sonography

    Time frame: Day1

    • MSOT: Correlation of the signal for total/oxygenated/deoxygenated hemoglobin determined with MSOT with sonographic parameters
  9. MSOT hb and histology

    Time frame: Day1

    • MSOT: Correlation of the signal for total/oxygenated/deoxygenated hemoglobin with with histological parameters
  10. MSOT Lipid and laboratory results

    Time frame: Day1

    • MSOT: Correlation of the signal for lipid determined with MSOT with laboratory chemical parameters
  11. MSOT Lipid and sonographic results

    Time frame: Day1

    MSOT: Correlation of the signal for lipid determined with MSOT with sonographic parameters parameters

  12. MSOT lipid and histology

    Time frame: Day1

    MSOT: Correlation of the signal for lipid determined with MSOT with histological parameters

  13. MSOT collagen and sonography

    Time frame: Day1

    • MSOT: Correlation of the signal for collagen determined with MSOT with sonographic parameters
  14. MSOT collagen and histology

    Time frame: Day1

    MSOT: Correlation of the signal for collagen determined with MSOT with histological parameters

  15. MSOT collagen and laboratory results

    Time frame: Day1

    • MSOT: Correlation of the signal for collagen determined with MSOT with laboratory chemical parameters
  16. ULM quantification and sonography

    Time frame: Day1

    Correlation of parameters of the quantified microvascular perfusion dynamics in the transplant kidney with sonography in transplanted kidney

Study contacts

Contact information is provided by the study sponsor or research team.

Adrian Regensburger, PD Dr. Dr.

CONTACT

[email protected]

0049 9131 33118

Ferdinand Hannah Knieling, PD Dr. Dr.

CONTACT

[email protected]

0049 9131 85 33118

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Acronym: ESTIMATOR

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 25, 2024
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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