Actively Recruiting
Optic Nerve Sheath Evaluation in Giant Cell Arteritis by Ultrasound
Led by Hôpital NOVO · Updated on 2025-09-12
190
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Giant Cell Arteritis (GCA) is a rare inflammation of large and medium-sized blood vessels, mainly affecting women around 70 years old. This research aims to evaluate if measuring the optic nerve sheath diameter (ONSD) by ultrasound can serve as a reliable diagnostic marker for GCA. Early and accurate diagnosis of GCA is crucial, as current recommended tests include imaging and temporal artery biopsy, which can be affected by prior corticosteroid treatment. Participants suspected of having GCA will undergo orbital ultrasound at the start of the study and again at six months if GCA is confirmed. This ultrasound method is non-invasive, widely available, and cost-effective, offering a potentially faster way to diagnose GCA. The study focuses on measuring the optic nerve sheath thickness to assess its diagnostic value. During the study, patients will receive orbital ultrasounds at enrollment and possibly after six months. Researchers will measure the optic nerve sheath diameter, assess its reproducibility, and study changes under treatment. They will also explore how this measurement relates to other GCA features such as extracranial involvement and visual symptoms. The primary outcome is the accuracy of the optic nerve sheath measurement at these time points for diagnosing GCA.
CONDITIONS
Brief Title
oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with suspected Giant Cell Arteritis
- Patient aged 50 years or older
You will not qualify if you...
- History of Giant Cell Arteritis
- History of polymyalgia rheumatica without initial PET scan
- History of retinal disease, demyelinating disease, or intracranial hypertension
- Use of corticosteroids greater than 0.5 mg/kg in the last 2 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - At enrollment (Day 0)
Participants undergo orbital ultrasound at the beginning of their participation to evaluate the optic nerve sheath diameter as a diagnostic marker for Giant Cell Arteritis (GCA).
1 visit (in-person) at enrollment
Duration - 6 months after enrollment
Participants with confirmed suspicion of GCA after initial tests have a follow-up orbital ultrasound at 6 months to assess the evolution of the optic nerve sheath diameter under treatment.
1 follow-up visit (in-person) at 6 months
Trial Site Locations
Total: 9 locations
1
Rhumatology departement - Centre Hospitalier Aix en Provence
Aix-en-Provence, France
Not Yet Recruiting
2
Rhumatology department - Centre Hospitalier Universitaire de Brest
Brest, France
Not Yet Recruiting
3
Internal Medecine Department- CHU Caen
Caen, France
Actively Recruiting
4
Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de Dijon
Dijon, France
Not Yet Recruiting
5
Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Nantes
Nantes, France
Not Yet Recruiting
6
Internal Medicine department - Hôpital Saint-Antoine
Paris, France
Not Yet Recruiting
7
Rhumatology department - Hôpital Bichat
Paris, France
Not Yet Recruiting
8
Rhumatology department - Hôpital NOVO - Pontoise site
Pontoise, France
Not Yet Recruiting
9
Rhumatology department - Centre Hospitalier Universitaire de Tours
Tours, France
Not Yet Recruiting
Research Team
M
Maryline DELATTRE
M
Mathilde WLODARCZYK
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here