Clinical trial NCT07001059: oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
Official title: oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Giant Cell Arteritis (GCA)
Keywords: Giant Cell Arteritis
Optic nerve sheath
Ultrasound
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 190
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)
timeFrame: At the patient enrollment visit and at 6 months
Secondary outcomes:
measure: Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.
timeFrame: At the patient enrollment visit and at 6 months
measure: Evaluate the diagnostic performance of ONSD in GCA.
timeFrame: At the patient enrollment visit and at 6 months
measure: Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.
timeFrame: At the patient enrollment visit and at 6 months
measure: Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.
timeFrame: At the patient enrollment visit and at 6 months
measure: Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement.
timeFrame: At the patient enrollment visit and at 6 months
measure: Assess the feasibility of ultrasound as a diagnostic tool for GCA.
timeFrame: At the patient enrollment visit and at 6 months
measure: Assess the feasibility of ultrasound as a diagnostic tool for GCA.
timeFrame: At the patient enrollment visit and at 6 months
measure: Assess the feasibility of ultrasound as a diagnostic tool for GCA.
timeFrame: At the patient enrollment visit and at 6 months
Other outcomes:
Locations:
city: Aix-en-Provence
country: France
facility: Rhumatology departement - Centre Hospitalier Aix en Provence
city: Brest
country: France
facility: Rhumatology department - Centre Hospitalier Universitaire de Brest
city: Caen
country: France
facility: Internal Medecine Department- CHU Caen
city: Dijon
country: France
facility: Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de Dijon
city: Nantes
country: France
facility: Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Internal Medicine department - Hôpital Saint-Antoine
city: Paris
country: France
facility: Rhumatology department - Hôpital Bichat
city: Pontoise
country: France
facility: Rhumatology department - Hôpital NOVO - Pontoise site
city: Tours
country: France
facility: Rhumatology department - Centre Hospitalier Universitaire de Tours
Study officials:
affiliation: Hôpital NOVO
name: Omar AL TABAA, Dr
role: PRINCIPAL_INVESTIGATOR
References: