Optic nerve sheath ultrasound for diagnosing giant cell arteritis
Official title: oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
Run by Hôpital NOVO · NCT07001059 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | Hôpital NOVO Academic / other |
| Locations | 9 sites (Aix-en-Provence and 8 other locations) |
| Status | Recruiting |
| Started | September 4, 2025 |
| Main results expected | March 31, 2028 |
| Study ends | March 31, 2028 |
| Registry record updated | September 12, 2025 |
| Trial ID | NCT07001059 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Prior small studies have reported optic nerve sheath thickening on ultrasound in GCA patients, providing preliminary supportive data though the method remains investigational.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Internal Medecine Department- CHU Caen
Caen, France Recruiting -
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 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
Show 3 more locations
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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
- Email: maryline.delattre@ght-novo.fr
- Phone: +330130754131
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Giant Cell Arteritis: Monitoring Disease Activity and Relapse Risk in Remission
This study tests tools that help monitor disease activity and predict relapses in people with giant cell arteritis who are in remission.
-
Combining vascular ultrasound and blood markers to improve diagnosis and monitoring of giant cell arteritis
This project will test whether adding extended ultrasound scans to new blood biomarkers can better predict relapse and tell active from inactive giant cell arteritis in people referred for suspected GCA.
-
Orbital blood-vessel inflammation in giant cell arteritis and ischemic optic neuropathy
This project will test whether advanced FDG PET/MRI with black-blood sequences plus OCT scans can tell if sudden optic nerve damage is due to giant cell arteritis or non-arteritic ischemic optic neuropathy in people aged 50 and older.
-
Personalized lab test to predict the best treatment for rheumatic diseases
This project tests a lab-based cell assay to see if it can predict which DMARD will work best for adults with autoimmune rheumatic diseases such as RA, PsA, axSpA, and GCA.
-
Stopping versus reducing tocilizumab for people with well-controlled giant cell arteritis
This trial will test whether stopping tocilizumab or reducing its dose better maintains remission in people with giant cell arteritis who have been on high-dose tocilizumab for at least 12 months and off steroids for at least three months.
-
Halo sign in GCA: how soon after steroids to perform Doppler ultrasound
This study tests whether timing of Doppler ultrasound after starting steroids affects the ability to see the halo sign in adults with giant cell arteritis.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.