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NCT Number: NCT07060274

Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients

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.

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Key information

Conditions

Giant Cell Arteritis (GCA) Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Doppler Ultrasound Giant Cell Arteritis Immune System Diseases Nervous System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier du Mans, Le Mans, Sarthe, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Doppler ultrasound

Procedure

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

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.

    Time frame: From Day 0 to Day 3 of corticosteroid therapy

Secondary outcomes

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

    Time frame: On Day 3, Day 7 and Day 15 of corticosteroid therapy

    With Doppler ultrasound, the following signs of vasculitis will be assessed : Difficulty compressing the temporal artery, Temporal artery occlusion, Temporal artery stenosis, Bilateral or unilateral halo sign and Presence of halo sign on vascular axes other than temporal arteries. The absence or presence of these signs will be reported and used to evaluate the disappearance of the halo sign over time during corticosteroid therapy.

  2. Assessment of other vascular axes on Day 3

    Time frame: On Day 3 of corticosteroid therapy

    Number of patients with positive echo-Doppler signs of vasculitis in subclavian, axillary, common/external/internal carotid and vertebral arteries.

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

    Time frame: On Day 7 of corticosteroid therapy

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

    Time frame: On Day 15 of corticosteroid therapy

  5. Correlation between histological arteritis and echo-doppler halo sign

    Time frame: On Day 0 of corticosteroid therapy

    Number of patients with positive histology on temporal artery biopsy (to be performed at investigator's discretion)

  6. Correlation between C-reactive protein (CRP) kinetics and disappearance of the halo sign

    Time frame: On Day 3 and Day 7 of corticosteroid therapy

    Number of patients with positive C-reactive protein (CRP) on Day 3 and Day 7

  7. Correlation between corticosteroid dose and disappearance of halo sign

    Time frame: From Day 0 to Day 15

    • Number of patients receiving methylprednisolone bolus
    • Number of patients receiving prednisone equivalent greater than or equal to 60mg per day

  8. Number of patients on Tocilizumab with disappearance of Halo sign on Day 15

    Time frame: On Day 15 of corticosteroid therapy

Study contacts

Contact information is provided by the study sponsor or research team.

Christelle JADEAU, MD, PhD

CONTACT

[email protected]

+332 44 71 07 81

Pierre LOZAC'H, MD

CONTACT

[email protected]

+332 43 43 29 12

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: Halo-A

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 11, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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