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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)

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05663333
Acronym
DOCTA
Enrollment
14
Registered
2022-12-23
Start date
2023-01-26
Completion date
2024-07-31
Last updated
2024-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Giant Cell Arteritis, Tomography, Optical Coherence

Keywords

Giant Cell Arteritis, Temporal Artery Biopsy, Full-field Optical Coherence Tomography

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.

Interventions

OTHERDynamic full-field optical coherence tomography analysis of temporal artery biopsy

Dynamic full-field optical coherence tomography analysis of temporal artery biopsy in the dermatology department before conventional histopathological analysis

Sponsors

Centre Hospitalier de Mâcon
CollaboratorOTHER
Centre Hospitalier William Morey - Chalon sur Saône
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomographyOutcome measure is assessed 15 days following temporal artery biopsyProvide 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

MeasureTime frameDescription
Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomographyOutcome measure is assessed 15 days following temporal artery biopsyProvide 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026