oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound (PETRUS)

Hôpital NOVO

Status: Not yet enrolling

Conditions: Giant Cell Arteritis (GCA)

Treatments: Diagnostic Test: orbital ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT07001059

2025-A00141-48 (Other Identifier)

CHRD 0524

Details and patient eligibility

About

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

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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190 participants in 1 patient group

Orbital ultrasounds

Experimental group

Description:

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.

Treatment:

Diagnostic Test: orbital ultrasound