oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 190
- Locations
- 9
- Primary Endpoint
- Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Orbital ultrasounds
Orbital ultrasounds on patients suspected of GCA at the enrollment (M0) and at 6 months if the suspicion of GCA is confirmed after all the tests realized at the enrollment.
Intervention: orbital ultrasound (Diagnostic Test)
Outcomes
Primary Outcomes
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
Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard. The clinical expert's evaluation will be blinded to the optic nerve sheath measurements.
Secondary Outcomes
- Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.(At the patient enrollment visit and at 6 months)
- Assess the feasibility of ultrasound as a diagnostic tool for GCA.(At the patient enrollment visit and at 6 months)
- Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.(At the patient enrollment visit and at 6 months)
- Evaluate the diagnostic performance of ONSD in GCA.(At the patient enrollment visit and at 6 months)
- Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.(At the patient enrollment visit and at 6 months)
- Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement.(At the patient enrollment visit and at 6 months)