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Clinical Trials/NCT05663333
NCT05663333CompletedNot Applicable

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

Centre Hospitalier William Morey - Chalon sur Saône1 site in 1 country14 target enrollmentStarted: January 26, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
14
Locations
1
Primary Endpoint
Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomography

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomography

Time Frame: 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 Outcomes

  • Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography(Outcome measure is assessed 15 days following temporal artery biopsy)

Investigators

Sponsor
Centre Hospitalier William Morey - Chalon sur Saône
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Maldiney

Doctor

Centre Hospitalier William Morey - Chalon sur Saône

Study Sites (1)

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