Optic nerve sheath ultrasound for diagnosing giant cell arteritis

oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound

This will try using ultrasound to measure the optic nerve sheath to see if it helps diagnose giant cell arteritis in people over 50 with suspected GCA.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 190 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Hôpital NOVO (Academic / other)
• Locations: 9 sites (Aix-en-Provence and 8 other locations)
• Trial ID: NCT07001059 on ClinicalTrials.gov

What this trial studies

The study uses orbital ultrasound to measure optic nerve sheath thickness in patients older than 50 who present with suspected giant cell arteritis at three French hospitals. Measurements will be obtained early in the diagnostic workup and compared with the standard diagnostic pathway (clinical evaluation, other imaging and/or temporal artery biopsy) to determine diagnostic accuracy. Patients who have recently received high-dose corticosteroids or who have certain eye or neurologic conditions are excluded because these factors can affect imaging. The goal is to determine whether this quick, non-invasive, widely available ultrasound marker can shorten time to diagnosis and reduce reliance on more invasive or less accessible tests.

Who should consider this trial

Good fit: Ideal candidates are people over 50 with new suspected giant cell arteritis who have not recently received high-dose corticosteroids and do not have prior GCA or specified eye/neurologic conditions.

Not a fit: People with a prior diagnosis of GCA, recent high-dose steroid treatment, a history of retinal disease, demyelinating disease, intracranial hypertension, or certain PMR histories are unlikely to benefit from this test in the study.

Why it matters

Potential benefit: If successful, this could offer a fast, non-invasive, widely available way to help diagnose GCA earlier and reduce the need for invasive testing.

How similar studies have performed: Prior small studies have reported optic nerve sheath thickening on ultrasound in GCA patients, providing preliminary supportive data though the method remains investigational.

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

Where this trial is running

Aix-en-Provence and 8 other locations

• Rhumatology departement - Centre Hospitalier Aix en Provence — Aix-en-Provence, France (Not_yet_recruiting)
• Rhumatology department - Centre Hospitalier Universitaire de Brest — Brest, France (Not_yet_recruiting)
• Internal Medecine Department- CHU Caen — Caen, France (Recruiting)
• Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de Dijon — Dijon, France (Not_yet_recruiting)
• Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Nantes — Nantes, France (Not_yet_recruiting)
• Internal Medicine department - Hôpital Saint-Antoine — Paris, France (Not_yet_recruiting)
• Rhumatology department - Hôpital Bichat — Paris, France (Not_yet_recruiting)
• Rhumatology department - Hôpital NOVO - Pontoise site — Pontoise, France (Not_yet_recruiting)
• Rhumatology department - Centre Hospitalier Universitaire de Tours — Tours, France (Not_yet_recruiting)

Study contacts

• Principal investigator: Omar AL TABAA, Dr — Hôpital NOVO
• Study coordinator: Maryline DELATTRE

Conditions Giant Cell Arteritis; Optic nerve sheath; Ultrasound