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) (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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 14

Contacts and Locations

Study Locations

• France
  • Saône-et-Loire
    • Chalon sur Saône, Saône-et-Loire, France, 71100
      • Centre Hospitalier William Morey - Chalon sur Saône

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Dynamic full-field optical coherence tomography analysis of temporal artery biopsy in the dermatology department before conventional histopathological analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography	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	Outcome measure is assessed 15 days following temporal artery biopsy

Collaborators and Investigators

• Sponsor: Centre Hospitalier William Morey - Chalon sur Saône
• Collaborators: Centre Hospitalier de Mâcon
• Investigators: Principal Investigator: Thomas Maldiney, Centre Hospitalier William Morey - Chalon sur Saône

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: PLoS One. 2023 Dec 19;18(12):e0296315. doi: 10.1371/journal.pone.0296315.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Giant Cell Arteritis; Full-field Optical Coherence Tomography; Temporal Artery Biopsy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Skin Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Muscular Diseases; Vasculitis; Skin Diseases, Vascular; Vasculitis, Central Nervous System; Polymyalgia Rheumatica; Giant Cell Arteritis; Arteritis
• Other Study ID Numbers: DOCTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No