NCT05246540

Brief Summary

Giant cell arteritis (GCA) is the most common vasculitis in adults. The diagnosis of GCA is evoked by the association of clinical signs and biological anomalies (inflammatory syndrome) in patients over 50 years of age. On the other hand, starting a treatment implies being certain of the diagnosis which requires performing a temporal artery biopsy under local anesthesia. This examination is therefore an invasive procedure for patients whose sensitivity is not optimal. This is why imaging techniques (echo-Doppler or MRI of the temporal arteries) have been developed to look for signs of vasculitis without the need to perform a biopsy. However, these examinations lack sensitivity (=falsely concluding the absence of GCA) and specificity (=falsely concluding the presence of GCA). Recently, advances in imaging, and in particular positron emission tomography (PET), have made it possible to visualize the cephalic arteries, including the temporal artery. The aim of this study is therefore to evaluate the sensitivity and specificity of PET of the cephalic arteries for the diagnosis of GCA and to compare them with those of echo-Doppler and MRI of the temporal arteries.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

February 9, 2022

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Sensitivity / specificity of cervical PET/CT for the diagnosis of GCA

    diagnosis retained by the clinician without question after 6 months of follow-up and treatment for at least 6 consecutive months

    6 months

Study Arms (1)

Patients

Other: Data collection

Interventions

Data collection

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

outpatient

You may qualify if:

  • Any patient for which the diagnosis of GCA is suspected and who underwent a cervical PET/CT

You may not qualify if:

  • previously diagnosed GCA, glycemia \> 7 mmol/L, PET CT performed more than 72 h after introduction of glucocorticoids, age \< 50 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

Related Publications (1)

  • Thibault T, Durand-Bailloud B, Soudry-Faure A, Greigert H, Drouet C, Devilliers H, Ramon A, Bejot Y, Martin L, Creuzot-Garcher C, Falvo N, Audia S, Cochet A, Bonnotte B, Alberini JL, Samson M. PET/CT of cranial arteries for a sensitive diagnosis of giant cell arteritis. Rheumatology (Oxford). 2023 Apr 3;62(4):1568-1575. doi: 10.1093/rheumatology/keac430.

MeSH Terms

Conditions

Giant Cell Arteritis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 18, 2022

Study Start

January 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2021

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations