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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Erlangen-Nürnberg Medical School

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • ULM and MSOT

    Device

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Patient with kidney transplant1 intervention

Trial outcomes

Primary outcomes

1

Visualization of microvascular architecture in the transplant kidney

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

Time frame
Day1
2

Quantification of microvascular dynamics in the transplanted kidney

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

Time frame
Day1
3

MSOT in human kidney transplant

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

Time frame
Day1

Secondary outcomes

1

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)

Time frame
Day1
2

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)

Time frame
Day1
3

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)

Time frame
Day1
4

ULM quantification and histology

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

Time frame
Day1

Other outcomes

Sponsors and contacts

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