US Time-Harmonic Elastography for the Early Detection of Childhood Glomerulonephritis

US Time-Harmonic Elastography for the Early Detection of Childhood Glomerulonephritis

Study Overview

• Status: Active, not recruiting
• Conditions: Glomerulonephritis

Detailed Description

Glomerulonephritis (GN) comprises a group of renal diseases characterized by glomerular and tubulointerstitial fibrosis secondary to glomerular inflammation and proliferation of the basement membrane, mesangial cells, or capillary endothelium triggered by immunologic mechanisms.(1) The glomerular filtration rate decreases with progression of chronic kidney disease (CKD), ultimately resulting in end-stage renal failure. Glomerulonephritis is the third most common cause of end-stage renal failure. Initial clinical signs of glomerulonephritis are nonspecific and subtle. Occasionally, affected patients present with hypertension, proteinuria, hematuria, raised serum creatinine level, weight gain, edema, or nephrotic syndrome.(2) The underlying pathologic changes are partly irreversible, and a prompt diagnosis with early initiation of treatment is of vital importance. The diagnosis is based on clinical, laboratory, and conventional US findings, whereas renal biopsy is considered the reference standard for a definitive diagnosis and fibrosis grading.(3,4) Unfortunately, this invasive procedure is associated with the risk of serious bleeding complications and therefore is not the method of choice for longitudinal monitoring.

Elastography, a Novel imaging modality that estimates tissue stiffness, especially for superficial organs such as the breast and Thyroid. In recent years, ultrasound elastography (UE) has been demonstrated in the liver and has been applied widely in the diagnosis and evaluation of liver diseases, such as chronic hepatitis, alcoholic liver diseases, and non alcoholic fatty liver diseases.(5,6) To date, renal allograft stiffness (elasticity) has been evaluated by magnetic resonance elastography (MRE) and ultrasound elastography (UE). However, UE application for native renal diseases has not been well up till now.(7) Conventional renal ultrasonography may be appropriate to evaluate kidney size, as well as to assess the echogenicity of the renal cortex, exclude obstruction, and determine the extent of fibrosis. However, It has no significant role in diagnosis of GN. US time-harmonic elastography depicts abnormal renal stiffness in glomerulonephritis, particularly among patients with early disease and preserved renal function.(8,9,10)

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71717
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patientswith acute glomerulonephritis either poststreptococcal , lupus, ANCA related, or Ig A nephritis . Diagnosis of such diseases will be done through usual clinical, laboratory , radiological and histopathological data

Description

Inclusion Criteria:

1. Age 1 month up to 18 years
2. Patientswith acute glomerulonephritis either poststreptococcal , lupus, ANCA related, or Ig A nephritis . Diagnosis of such diseases will be done through usual clinical, laboratory , radiological and histopathological data

Exclusion Criteria:

patients with clinical, laboratory , or radiological evidence of chronic kidney disease

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The diagnostic performance of US time-harmonic elastography for the early detection of glomerulonephritis will be assessed with calculation of its sensitivity ,specificity and accuracy	1 week

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2021
• Primary Completion (ANTICIPATED): September 30, 2022
• Study Completion (ANTICIPATED): October 30, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 5, 2020
• First Posted (ACTUAL): October 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Nephritis; Glomerulonephritis
• Other Study ID Numbers: Glomerulonephritis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No