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)

Acute Kidney Injury Clinical Trial

— NEPHROCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05728216
• Other study ID #: NEPHROCT
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: February 2023
• Source: Centre Hospitalier William Morey - Chalon sur Saône
• Contact: Thomas Maldiney
• Phone: +33 3 85 91 01 11
• Email: thomas.maldiney[@]ch-chalon71.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 30, 2024
• Est. primary completion date: October 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic
• Tomography, Optical Coherence
• Wounds and Injuries

Intervention

Other:
• Dynamic full-field optical coherence tomography analysis of kidney biopsy
Dynamic full-field optical coherence tomography analysis of kidney biopsy in the nephrology department before conventional histopathological analysis

Locations

Country	Name	City	State
France	Centre Hospitalier William Morey - Chalon sur Saône	Chalon sur Saône	Saône-et-Loire

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier William Morey - Chalon sur Saône	Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

References & Publications (2)

Hull KL, Adenwalla SF, Topham P, Graham-Brown MP. Indications and considerations for kidney biopsy: an overview of clinical considerations for the non-specialist. Clin Med (Lond). 2022 Jan;22(1):34-40. doi: 10.7861/clinmed.2021-0472. Epub 2021 Dec 17. — View Citation

Jain M, Robinson BD, Salamoon B, Thouvenin O, Boccara C, Mukherjee S. Rapid evaluation of fresh ex vivo kidney tissue with full-field optical coherence tomography. J Pathol Inform. 2015 Sep 28;6:53. doi: 10.4103/2153-3539.166014. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histopathological analysis of elementary lesions in nephropathology with dynamic full-field optical coherence tomography	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	Outcome measure is assessed 15 days following kidney biopsy
Secondary	Histopathological analysis of healthy kidney biopsy with dynamic full-field optical coherence tomography	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	Outcome measure is assessed 15 days following kidney biopsy