Imaging tiny kidney blood vessels in adults with proteinuria or active urinary sediment using ultrasound localization microscopy
Characterization of Renal Microvascular Alterations in Patients With Active Urinary Sediment and/or Proteinuria Using Ultrasound Localization Microscopy
University of Erlangen-Nürnberg Medical School · NCT07469059
This project will use a special ultrasound method called Ultrasound Localization Microscopy (ULM) to see if it can non-invasively show and measure tiny blood vessels in adult kidneys of people with proteinuria or active urinary sediment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT07469059 on ClinicalTrials.gov |
What this trial studies
This observational project will image the renal microvascular architecture in adults who have proteinuria and/or active urinary sediment using Ultrasound Localization Microscopy (ULM). Participants are adults already scheduled for a clinically indicated kidney biopsy; ULM imaging is performed non-invasively, typically with a contrast agent (SonoVue), to capture microvascular flow and structure. The ULM images will be compared with clinical and histologic information to characterize microvascular alterations. Pregnant or breastfeeding people and those with a known allergy or contraindication to the contrast agent are excluded.
Who should consider this trial
Good fit: Adults (≥18) with proteinuria greater than 1 g/g creatinine and/or active urinary sediment who are already scheduled for a medically indicated kidney biopsy and can safely receive SonoVue.
Not a fit: People who are pregnant, breastfeeding, allergic to SonoVue, or who do not have significant proteinuria or active urinary sediment are unlikely to benefit from this imaging approach.
Why it matters
Potential benefit: If successful, this could provide a non-invasive way to detect and monitor microvascular kidney damage and potentially reduce reliance on invasive biopsies.
How similar studies have performed: Early preclinical work and some pilot human studies using contrast-enhanced ultrasound and ULM have shown promise for imaging microvessels, but applying ULM to human renal microvasculature remains relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Evidence of active urinary sediment and/or proteinuria \>1 g/g creatinine * Indication for kidney biopsy as part of study-independent diagnostics * Written informed consent Exclusion Criteria: * Known allergic disposition to SonoVue® * Contraindication to the use of SonoVue® * Pregnancy * Breastfeeding mothers
Where this trial is running
Erlangen, Bavaria
- University Hospital Erlangen — Erlangen, Bavaria, Germany (RECRUITING)
Study contacts
- Study coordinator: Ferdinand Knieling, MD, PhD, MHBA
- Email: ferdinand.knieling@uk-erlangen.de
- Phone: 091318533118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nephritis, kidney, ultrasound localization microscopy