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)

NCT05663333 | Completed

• 1 other identifier: DOCTA
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Giant Cell Arteritis; Tomography, Optical Coherence

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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

  Outcome measure is assessed 15 days following temporal artery biopsy

Secondary Outcomes (1)

• Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography

  Outcome measure is assessed 15 days following temporal artery biopsy

Study Arms (1)

DOCTA cohort

Patients \> 50 years of age with suspected giant cell arteritis requiring temporal artery biopsy in the dermatology department

Other: Dynamic full-field optical coherence tomography analysis of temporal artery biopsy

Interventions

Dynamic full-field optical coherence tomography analysis of temporal artery biopsy OTHER

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

DOCTA cohort

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patient \> 50 years of age with suspected giant cell arteritis who received temporal artery biopsy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier William Morey - Chalon sur Saône: lead
• Centre Hospitalier de Mâcon: collaborator

Study Sites (1)

Centre Hospitalier William Morey - Chalon sur Saône

Chalon-sur-Saône, Saône-et-Loire, 71100, France

Location

Related Publications (2)

• 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.

  PMID: 34235884 BACKGROUND

• 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.

  PMID: 32866179 BACKGROUND

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Thomas Maldiney

  Centre Hospitalier William Morey - Chalon sur Saône

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: January 26, 2023
• Primary Completion: June 30, 2024
• Study Completion: July 31, 2024
• Last Updated: August 22, 2024

Record last verified: 2024-08

Locations

FR (1)