oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: orbital ultrasound.
- Who it may be relevant to
- Registry conditions: Giant Cell Arteritis (GCA). Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis
Detailed description
Giant Cell Arteritis (GCA) is a vasculitis affecting large and medium-sized vessels. It predominantly occurs in women, with a sex ratio of 3:1, and mainly affects individuals around 70 years of age. GCA is a rare condition, with an incidence of approximately 10 cases per 100,000 people in France.
Current recommendations suggest using imaging techniques and/or temporal artery biopsy (TAB) based on the clinical resources available. The key challenge in suspected cases of GCA is to establish a rapid diagnosis.
It is important to note that false-negative imaging results may occur if corticosteroid treatment is initiated prior to imaging: after 3 days for PET-CT, 5 to 7 days for Doppler ultrasound, and up to 14 days for TAB.
Diagnosing GCA is not always easy and depends on depends on the prompt performance of complementary examinations. Studies have shown that the optic nerve sheath is thickened on ultrasound in patients with GCA. In this context, the investigator aims to evaluate the measurement of the optic nerve sheath via ultrasound for diagnosing GCA. Ultrasound offers a faster, non-invasive, widely available, and cost-effective diagnostic tool.
Interventions
- Diagnostic test orbital ultrasound
orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.
Primary outcome measures
- Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA) [Time frame: At the patient enrollment visit and at 6 months]
Secondary outcome measures (8)
- Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound. [Time frame: At the patient enrollment visit and at 6 months]
- Evaluate the diagnostic performance of ONSD in GCA. [Time frame: At the patient enrollment visit and at 6 months]
- Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA. [Time frame: At the patient enrollment visit and at 6 months]
- Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA. [Time frame: At the patient enrollment visit and at 6 months]
- Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement. [Time frame: At the patient enrollment visit and at 6 months]
- Assess the feasibility of ultrasound as a diagnostic tool for GCA. [Time frame: At the patient enrollment visit and at 6 months]
- Assess the feasibility of ultrasound as a diagnostic tool for GCA. [Time frame: At the patient enrollment visit and at 6 months]
- Assess the feasibility of ultrasound as a diagnostic tool for GCA. [Time frame: At the patient enrollment visit and at 6 months]
Eligibility criteria
Inclusion criteria
- Patient with suspected GCA
- Patient over 50 years
Exclusion criteria
- Patient with history of GCA
- Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan
- Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension
- Use of corticosteroids > 0.5mg/kg in the last 2 weeks
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 9 centers
- Rhumatology departement - Centre Hospitalier Aix en Provence — Aix-en-Provence
- Rhumatology department - Centre Hospitalier Universitaire de Brest — Brest
- Internal Medecine Department- CHU Caen — Caen
- Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de D — Dijon
- Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Na — Nantes
- Internal Medicine department - Hôpital Saint-Antoine — Paris
- Rhumatology department - Hôpital Bichat — Paris
- Rhumatology department - Hôpital NOVO - Pontoise site — Pontoise
- … and 1 more center
Identifiers
NCT: NCT07001059 · CHRD 0524 · 2025-A00141-48