Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients

NCT ID: NCT07060274

Last Updated: 2025-07-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Timeframe for Halo sign resolution on Doppler ultrasound

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

Group Type: EXPERIMENTAL

Doppler Ultrasound

Intervention Type: PROCEDURE

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

Interventions

Doppler Ultrasound

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier le Mans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier du Mans

Le Mans, Sarthe, France

CHU d'Angers

Angers, , France

CHU Caen Normandie

Caen, , France

CHU Dijon - Hôpital François Mitterrand

Dijon, , France

Groupe hospitalier La Rochelle-Ré-Aunis

La Rochelle, , France

CHU Nantes

Nantes, , France

Countries

France

Central Contacts

Christelle JADEAU, MD, PhD

Role: CONTACT

cjadeau@ch-lemans.fr

+332 44 71 07 81

Pierre LOZAC'H, MD

Role: CONTACT

plozach@ch-lemans.fr

+332 43 43 29 12

Facility Contacts

Christelle JADEAU, MD, PhD

Role: primary

cjadeau@ch-lemans.fr

+332 44 71 07 81

Christian LAVIGNE, MD, PhD

Role: primary

ChLavigne@chu-angers.fr

+332 41 35 77 00

Hubert DE BOYSSON, MD, PhD

Role: primary

deboysson-h@chu-caen.fr

+332 31 06 46 78

Hélène GREIGERT, MD

Role: primary

helene.greigert@chu-dijon.fr

+333 80 29 34 09

Christophe RONCATO, MD

Role: primary

Christophe.RONCATO@ght-atlantique17.fr

+335 46 45 51 89

Olivier ESPITIA, MD

Role: primary

Olivier.ESPITIA@chu-nantes.fr

+332 40 08 33 55

Other Identifiers

CHM-2025/S06/02

Identifier Type: -

Identifier Source: org_study_id