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)

Sponsor
Centre Hospitalier William Morey - Chalon sur Saône (Other)
Overall Status
Recruiting
CT.gov ID
NCT05663333
Collaborator
Centre Hospitalier de Mâcon (Other)
100
1
18.1
5.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Dynamic full-field optical coherence tomography analysis of temporal artery biopsy

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Anticipated Study Start Date :
Jan 26, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Histopathological analysis of healthy temporal artery biopsy with dynamic full-field optical coherence tomography [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 Outcome Measures

  1. Histopathological features of giant cell arteritis with dynamic full-field optical coherence tomography [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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier William Morey - Chalon sur Saône Chalon sur Saône Saône-et-Loire France 71100

Sponsors and Collaborators

  • Centre Hospitalier William Morey - Chalon sur Saône
  • Centre Hospitalier de Mâcon

Investigators

  • Principal Investigator: Thomas Maldiney, Centre Hospitalier William Morey - Chalon sur Saône

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Thomas Maldiney, Doctor, Centre Hospitalier William Morey - Chalon sur Saône
ClinicalTrials.gov Identifier:
NCT05663333
Other Study ID Numbers:
  • DOCTA
First Posted:
Dec 23, 2022
Last Update Posted:
Jan 27, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Thomas Maldiney, Doctor, Centre Hospitalier William Morey - Chalon sur Saône
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2023