Clinical trial NCT05663333: 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)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Giant Cell Arteritis
Tomography, Optical Coherence
Keywords: Giant Cell Arteritis
Temporal Artery Biopsy
Full-field Optical Coherence Tomography
Lead sponsor: Centre Hospitalier William Morey - Chalon sur Saône
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Mâcon
First posted: 2022-12-23
Enrollment: 14
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient \> 50 years of age with suspected giant cell arteritis who received temporal artery biopsy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following temporal artery biopsy
Secondary outcomes:
measure: Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography
timeFrame: Outcome measure is assessed 15 days following temporal artery biopsy
Other outcomes:
Locations:
city: Chalon sur Saône
country: France
facility: Centre Hospitalier William Morey - Chalon sur Saône
state: Saône-et-Loire
Study officials:
affiliation: Centre Hospitalier William Morey - Chalon sur Saône
name: Thomas Maldiney
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maz M, Chung SA, Abril A, Langford CA, Gorelik M, Guyatt G, Archer AM, Conn DL, Full KA, Grayson PC, Ibarra MF, Imundo LF, Kim S, Merkel PA, Rhee RL, Seo P, Stone JH, Sule S, Sundel RP, Vitobaldi OI, Warner A, Byram K, Dua AB, Husainat N, James KE, Kalot MA, Lin YC, Springer JM, Turgunbaev M, Villa-Forte A, Turner AS, Mustafa RA. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Giant Cell Arteritis and Takayasu Arteritis. Arthritis Rheumatol. 2021 Aug;73(8):1349-1365. doi: 10.1002/art.41774. Epub 2021 Jul 8.
citation: Maldiney T, Greigert H, Martin L, Benoit E, Creuzot-Garcher C, Gabrielle PH, Chassot JM, Boccara C, Balvay D, Tavitian B, Clement O, Audia S, Bonnotte B, Samson M. Full-field optical coherence tomography for the diagnosis of giant cell arteritis. PLoS One. 2020 Aug 31;15(8):e0234165. doi: 10.1371/journal.pone.0234165. eCollection 2020.