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Super-resolution ultrasound contrast combined with viscoelastic ultrasound for non-invasive evaluation of fibrosis in chronic kidney disease: A single-center diagnostic trial

Super-resolution ultrasound contrast combined with viscoelastic ultrasound for non-invasive evaluation of fibrosis in chronic kidney disease: A single-center diagnostic trial

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600119156
Enrollment
Unknown
Registered
2026-02-24
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic kidney disease

Interventions

Gold Standard:Percentage of interstitial fibrosis and tubular atrophy in renal cortical biopsy pathology
Index test:Joint model of STVi and SR-CEUS

Sponsors

Peking University Shenzhen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >=18 years old; Patients were in stable clinical condition and could cooperate with ultrasound examination (able to complete short-term breath holding/breathing cooperation, lying flat or on the side), and signed informed consent. 2. Consistent with the diagnosis of CKD; 3. Renal biopsy specimens with at least 8 glomeruli that could be evaluated under light microscopy and sufficient renal cortex to complete the IFTA proportion estimation; 4. Routine ultrasound, STVi and SR-CEUS were performed within one week after renal biopsy. 5. Complete baseline data (including but not limited to Scr/eGFR, urinary albumin/proteinuria, blood pressure, and main medications) were available;

Exclusion criteria

Exclusion criteria: 1. Acute kidney injury or acute exacerbation requiring urgent management has an "acute/rapidly progressive state" that may lead to short-term pathology-imaging mismatch or significant intervention bias; 2. Initiation or significant adjustment of immunosuppressive/hormonal therapies that affect the inflammation-fibrosis phenotype within 1 week before or after biopsy or ultrasound examination; 3. Incomparable measurement or obvious confounding factors caused by anatomical structure/hemodynamic factors, such as renal artery stenosis or renal artery stenosis indicated by ultrasound/Doppler; Urinary obstruction/hydronephrosis; Renal tumors, multiple renal cysts, tumors, etc.; 4. Contraindications of SonoVue venography: allergy to components, known right-to-left shunt, severe pulmonary hypertension (pulmonary arterial pressure >90 mmHg), uncontrolled systemic hypertension, ARDS, etc. 5. Pregnancy; 6. Other conditions affecting the reproducibility: extreme obesity (BMI>35 kg/m^2) or poor acoustic window that prevented effective ROI acquisition, investigator's judgment that they were not suitable for enrollment or could not complete the follow-up; 7. Image quality control was not up to standard. Renal lesions seriously affect the accuracy of measurement: multiple renal cysts, multiple renal calculi, renal dysplasia, renal mass, etc.

Design outcomes

Primary

MeasureTime frame
Pathological biopsy showed mild fibrosis;Pathological biopsy showed moderate to severe fibrosis;

Countries

China

Contacts

Public ContactZhu Yixin

Peking University Shenzhen Hospital

zyx520@pkuszh.com+86 755 83923333

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026