Halo sign in GCA: how soon after steroids to perform Doppler ultrasound

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study looks at adults 50 and older with newly diagnosed giant cell arteritis who have not yet begun corticosteroid therapy. It uses Doppler ultrasound of the temporal arteries to observe the halo sign after initiation of steroids, aiming to clarify how quickly the halo sign may disappear. The goal is to determine the optimal timing for ultrasound to support rapid, non-invasive diagnosis and monitoring. Participating centers include facilities in Le Mans, Angers, and Caen. The study is led by Centre Hospitalier Le Mans and involves patients who are steroid-naïve at enrollment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged 50 and over
* Without legal protection.
* Meeting GCA classification criteria as defined by ACR 2022 with the presence of a halo sign-unilateral or bilateral-on Doppler ultrasound of the temporal artery.
* Newly diagnosed with an indication for corticosteroid treatment.
* Have not yet received corticosteroid treatment for GCA.
* No contraindication to corticosteroid treatment.
* Person affiliated with or benefiting from a social security scheme.
* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination necessary for the research).

Exclusion Criteria:

* Patients with a relapse of Giant Cell Arteritis (GCA).
* Patients who have previously undergone a temporal artery biopsy (TAB), including for other reasons.
* Patients who have received oral corticosteroid treatment in the past month or are currently on corticosteroid therapy (excluding hydrocortisone or local corticosteroids).
* Patients with other types of vasculitis that may constitute a differential diagnosis: presence of antibodies against the cytoplasm of neutrophils (ANCA), positive syphilis serology, positivity of an IGRA test (Interferon Gamma Release Assay).
* Patients having received immunosuppressive treatment or biotherapy in the month prior to inclusion. If the patient's condition warrants the use of biotherapy or immunosuppressive treatment, its initiation will be delayed until after Day 7 to avoid interfering with the Doppler procedure.

Where it's running

• Centre Hospitalier du Mans
  Le Mans, Sarthe, France Recruiting
• CHU d'Angers
  Angers, France Recruiting
• Groupe hospitalier La Rochelle-Ré-Aunis
  La Rochelle, France Recruiting
• CHU Nantes
  Nantes, France Recruiting
• CHU Caen Normandie
  Caen, France Not yet recruiting
• CHU Dijon - Hôpital François Mitterrand
  Dijon, France Not yet recruiting

Study contacts

• Study coordinator: Christelle JADEAU, MD, PhD
• Email: cjadeau@ch-lemans.fr
• Phone: +332 44 71 07 81

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.