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Prediction of Renal Parenchymal Damage of CAKUT

NCT04537364 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 234

Last updated 2023-11-09

No results posted yet for this study

Summary

To establish the prediction of the renal damage and renal development deficiency in congenital anomalies of kidney and urinary tract (CAKUT), a diagnostic accuracy study on MRI-DWI combined with urinary microprotein detection is to carried out comparing with DMSA scan as the golden standard for renal damage.

Conditions

  • CAKUT

Interventions

DIAGNOSTIC_TEST

combined diagnosis of renal parenchymal damage

This study is an observational study to evaluate the accuracy of renal parenchymal damage combined diagnosis with no intervention. All patients from the cohort accept MRI-DWI scan，the urinary biomarkers detection, disease gene detection and DMSA scan. 1. This combined diagnosis includes MRI-DWI scan and the urinary biomarkers detection. MRI-DWI： All the scans are performed using the MagnetomVerio 3.0T magnetic resonance imaging system from Siemens. Urinary polypeptide collection: Urine samples requirements: volume between 50-100ml, specific gravity \>1.010. Immunomagnetic beads isolation technique is used to collect polypeptide. 2. The reference standard is DMSA scan: Intravenous injection of 99mTC-DMSA5mCi is followed by anterior and posterior planar imaging of the renal area 1 hour later. The DMSA scan images are read by 2 trained radiologists and confirmed by the special doctor of the center for diagnosis and treatment of renal and urinary diseases at the same time.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-10-31
Completion
2023-10-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04537364 on ClinicalTrials.gov