Histopathological Analysis of Temporal Artery Biopsy Following Dynamic Full-field Optical Coherence Tomography, a Comparison to Conventional Histopathological Findings in Patients With Suspected Giant Cell Arteritis (DOCTA)

Completed

• Conditions: Giant Cell Arteritis; Tomography, Optical Coherence
• Interventions: Other: Dynamic full-field optical coherence tomography analysis of temporal artery biopsy

• Registration Number: NCT05663333
• Lead Sponsor: Centre Hospitalier William Morey - Chalon sur Saône

Brief Summary

Giant cell arteritis (GCA) is a type of large vessel granulomatous vasculitis responsible for the inflammation of the aorta and the branches of the external carotid, notably temporal arteries. The diagnosis of GCA relies upon the identification of vasculitis following histopathological analysis of temporal artery biopsy (TAB) showing mononuclear cells infiltration, fragmentation of the internal elastic lamina as well as significant intimal hyperplasia. Apart from its lack of sensitivity, one of the weaknesses of TAB is the delay in obtaining the result due to the time required to prepare the sample for histological analysis. Pursuing the idea to improve TAB performances, our group recently demonstrated the use of full-field optical coherence tomography (FF-OCT) to visualize structural changes associated with the inflammatory processes of GCA. The present work suggests a further use of dynamic FF-OCT on TAB for a direct visualization of the mononuclear cells infiltration to ensure rapid on-site diagnosis of GCA.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-15
• Study First Submitted QC: 2022-12-15
• Study First Posted: 2022-12-23
• Study Start: 2023-01-26
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• patient > 50 years of age with suspected giant cell arteritis who received temporal artery biopsy between start study date and primary completion date

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DOCTA cohort	Dynamic full-field optical coherence tomography analysis of temporal artery biopsy	Patients \> 50 years of age with suspected giant cell arteritis requiring temporal artery biopsy in the dermatology department

Primary Outcome Measures

Name	Time	Method
Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomography	Outcome measure is assessed 15 days following temporal artery biopsy	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify the normal structures of a temporal artery biopsy, i.e. the tripartite architecture with a clear distinction between intima (endothelial cells), media (vascular smooth muscle cells) and adventitia, both internal and external elastic lamina, and vasa vasorum

Secondary Outcome Measures

Name	Time	Method
Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography	Outcome measure is assessed 15 days following temporal artery biopsy	Provide a better understanding of the ability of dynamic full-field optical coherence tomography to identify histopathological features of giant cell arteritis, i.e. infiltration of mononuclear cells in the three layers of the artery, fragmentation of the internal elastic lamina, intimal hyperplasia and neoangiogenesis

Trial Locations

Locations (1)

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