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

NCT06472947 | Recruiting

• 1 other identifier: NTX_ULM_MSOT
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Kidney Transplant; Kidney Biopsy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• ULM visuals and histology

  Day1

• ULM visuals and laboratory results

  Day1

• ULM visuals and standard sonography

  Day1

• ULM quantification and histology

  Day1

• ULM quantification and laboratory results

  Day1

Study Arms (1)

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

Device: ULM and MSOT

Interventions

ULM and MSOT DEVICE

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

Patient with kidney transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 patients with kidney transplant and indication for kidney biopsy

You may qualify if:

• kidney transplant
• indication for biopsy set in clinical routine
• minimum 18 years of age
• written consent

You may not qualify if:

• allergy against contrast agents/ SonoVue
• tatoos in examined areas
• contraindication against SonoVue
• pregnant women
• breast feeding women

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Department of Pediatrics and Adolescent Medicine

Erlangen, Bavaria, 91054, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood and urine tests kidney tissue (biopsy)

Study Officials

• Ferdinand Knieling, PD Dr. Dr.

  FAU Erlangen-Nuremberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ferdinand Hannah Knieling, PD Dr. Dr.

CONTACT

0049 9131 85 33118; ferdinand.knieling@uk-erlangen.de

Adrian Regensburger, PD Dr. Dr.

CONTACT

0049 9131 33118; adrian.regensburger@uk-erlangen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Pediatric Translational Imaging Laboratory

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: June 25, 2024
• Study Start: June 18, 2024
• Primary Completion (Estimated): January 18, 2028
• Study Completion (Estimated): January 18, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)