Histopathological Analysis of Renal Biopsies With Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings for the Diagnosis of Either Acute Kidney Injury or Chronic Kidney Disease in Routine Practices (NEPHROCT)

Recruiting

• Conditions: Tomography, Optical Coherence; Acute Kidney Injury; Chronic Kidney Diseases
• Interventions: Other: Dynamic full-field optical coherence tomography analysis of kidney biopsy

• Registration Number: NCT05728216
• Lead Sponsor: Centre Hospitalier William Morey - Chalon sur Saône

Brief Summary

Kidney biopsy play a key role for the investigation of either acute kidney injury or chronic kidney disease. Despite possible complications due to the invasive nature of the biopsy, such procedure is still essential in a number of clinical situations to improve the diagnosis specificity of kidney disease, better inform about its prognosis and guide the management of a future treatment. Pursuing the idea to improve both performance and rapidity associated with the histopathological analysis of kidney biopsy, with a possible recourse to artificial intelligence-based renal pathology, the present study intends to assess the impact of direct histopathological examination of kidney biopsy with dynamic full-field optical coherence tomography in routine practices for the diagnosis of either acute kidney injury or chronic kidney disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-01
• Study First Submitted: 2023-02-04
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients > 18 years of age with suspected acute kidney injury requiring biopsy in the nephrology department
• patients > 18 years of age with suspected chronic kidney disease requiring biopsy in the nephrology department

Exclusion Criteria

• inability to perform dynamic full-field optical coherence tomography observation at the moment of kidney biopsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NEPHROCT cohort	Dynamic full-field optical coherence tomography analysis of kidney biopsy	Patients \> 18 years of age with suspected acute kidney injury or chronic kidney disease requiring biopsy in the nephrology department

Primary Outcome Measures

Name	Time	Method
Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography	Outcome measure is assessed 15 days following kidney biopsy	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize common glomerular (abnormal / double contour of the glomerular basement membrane, focal segmental glomerulosclerosis, collapse of the glomerular tuft, proliferation of glomerular epithelial cells, endocapillary proliferation, mesangial expansion, necrosis and proliferation with mild increase in extracapillary cells...), vascular (hyaline change, fibrinoid change / necrosis, thrombosis, inflammation or necrosis of vascular walls, arteriosclerosis) and tubulointerstitial (acute tubular necrosis, cytoplasmic vacuolization, lipid inclusions in proximal / distal tubular cells, atrophy of tubules, edema, inflammation or interstitial fibrosis, cortical necrosis) lesions seen in kidney biopsy

Secondary Outcome Measures

Name	Time	Method
Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography	Outcome measure is assessed 15 days following kidney biopsy	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify and characterize healthy glomerular (glomerular basement membrane, glomerular tuft, endothelial, epithelial, and mesangial cells, glomerular capsule and capsular space, glomerular capillaries), vascular (afferent and efferent arterioles, interlobular artery) and tubulointerstitial (proximal and distal tubular cells, normal cytoplasmic aspect) structures seen in kidney biopsy

Trial Locations

Locations (1)

Centre Hospitalier William Morey - Chalon sur Saône; 🇫🇷 Chalon sur Saône, Saône-et-Loire, France