Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients

NCT07060274 | Not Yet Recruiting

• 1 other identifier: CHM-2025/S06/02
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 6

Brief Summary

Giant cell arteritis (GCA) is a rare disease characterized by vasculitis of the large arterial trunks targeting the thoracic aorta and its dividing branches, affecting adults over the age of 50. Vasculitis lesions cause thickening of the arterial wall, visible on temporal artery biopsy (TAB) or vascular imaging (echo-Doppler, angio-CT, angio-MRI, 18FDG PET-CT). This is a severe disease that can lead to blindness. Early diagnosis is essential, so that steroids therapy can be started as soon as possible to prevent complications. Doppler ultrasonography of the temporal arteries provides rapid, non-invasive diagnostic support. However, the recommendations do not specify how soon temporal artery Doppler should be performed after steroids treatment, except that the halo sign would disappear after about 5 days on steroids. Sensitivity seems to be better when the examination is performed early, but the time taken for the halo sign to disappear is unknown. The investigator suggests that the disappearance of the temporal artery halo sign in GCA patients is observed earlier than D14 of steroids treatment usually reported in the literature. He speculates that the sensitivity of the temporal artery Doppler decreases as early as D3 of steroids treatment, and that beyond D7 it is not useful to perform this examination as its sensitivity becomes too low.

Conditions

Giant Cell Arteritis (GCA); Doppler Ultrasound

Keywords

Giant cell arteritis; echo-Doppler; Doppler ultrasonography; Halo sign; steroids

Outcome Measures

Primary Outcomes (1)

• Number of patients with GCA AND temporal artery Doppler WITH a halo sign on Day 0 of corticosteroid therapy and disappearing on Day 3.

  From Day 0 to Day 3 of corticosteroid therapy

Secondary Outcomes (8)

• Assessment of vasculitis via Doppler on Day 3, Day 7, and Day 15

  On Day 3, Day 7 and Day 15 of corticosteroid therapy

• Assessment of other vascular axes on Day 3

  On Day 3 of corticosteroid therapy

• Assessment of the number of patients with disappearance of the halo sign on Day 7

  On Day 7 of corticosteroid therapy

• Assessment of the number of patients with disappearance of the halo sign on Day 15

  On Day 15 of corticosteroid therapy

• Correlation between histological arteritis and echo-doppler halo sign

  On Day 0 of corticosteroid therapy

Study Arms (1)

Timeframe for Halo sign resolution on Doppler ultrasound

EXPERIMENTAL

Doppler ultrasound of temporal arteries at D0, D3 and D7 (+/- D15) after initiation of corticosteroid therapy.

Procedure: Doppler Ultrasound

Interventions

Doppler Ultrasound PROCEDURE

Doppler ultrasound of temporal arteries at D0, D3 and D7 (+ D15 if halo detected at D7) after initiation of corticosteroid therapy.

Timeframe for Halo sign resolution on Doppler ultrasound

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50 and over
• Without legal protection.
• Meeting GCA classification criteria as defined by ACR 2022.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Centre Hospitalier le Mans: lead

Study Sites (6)

Centre Hospitalier du Mans

Le Mans, Sarthe, 72000, France

Location

CHU d'Angers

Angers, 49100, France

Location

CHU Caen Normandie

Caen, 14000, France

Location

CHU Dijon - Hôpital François Mitterrand

Dijon, 21000, France

Location

Groupe hospitalier La Rochelle-Ré-Aunis

La Rochelle, 17000, France

Location

CHU Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Christelle JADEAU, MD, PhD

CONTACT

+332 44 71 07 81; cjadeau@ch-lemans.fr

Pierre LOZAC'H, MD

CONTACT

+332 43 43 29 12; plozach@ch-lemans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single group is followed during 15 days with steroids treatment and the time until the halo disappears is monitored.

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 11, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 11, 2025

Record last verified: 2025-07

Locations

FR (6)