Giant Cell Arteritis (GCA)Halo-ANCT07060274
Halo Sign Vanishing Time After Steroids Outbreak in GCA Patients
A study testing Doppler Ultrasound in people with Giant Cell Arteritis (GCA) and Doppler Ultrasound, run by Centre Hospitalier le Mans at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA), Doppler Ultrasound
- What is being tested?
- Doppler Ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 6 sitesFrance
- Study dates
- 27 Feb 2026to Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU d'Angers
Angers, 49100
Christian LAVIGNE, MD, PhD, +332 41 35 77 00, ChLavigne@chu-angers.fr
Christian LAVIGNE, MD, PhD
- Not yet recruiting
CHU Caen Normandie
Caen, 14000
Hubert DE BOYSSON, MD, PhD, +332 31 06 46 78, deboysson-h@chu-caen.fr
Hubert DE BOYSSON, MD, PhD
- Not yet recruiting
CHU Dijon - Hôpital François Mitterrand
Dijon, 21000
Hélène GREIGERT, MD, +333 80 29 34 09, helene.greigert@chu-dijon.fr
Hélène GREIGERT, MD
- Recruiting
Groupe hospitalier La Rochelle-Ré-Aunis
La Rochelle, 17000
Christophe RONCATO, MD, +335 46 45 51 89, Christophe.RONCATO@ght-atlantique17.fr
Christophe RONCATO, MD
- Recruiting
Centre Hospitalier du Mans
Le Mans, Sarthe, 72000
Christelle JADEAU, MD, PhD, +332 44 71 07 81, cjadeau@ch-lemans.fr
Pierre LOZAC'H, MD
- Recruiting
CHU Nantes
Nantes, 44000
Olivier ESPITIA, MD, +332 40 08 33 55, Olivier.ESPITIA@chu-nantes.fr
Olivier ESPITIA, MD
About this study
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
- Being tested
- Doppler Ultrasound
- Keywords
- Giant cell arteritis, echo-Doppler, Doppler ultrasonography, Halo sign, steroids
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler UltrasoundProcedure or surgery
Doppler ultrasound of temporal arteries at D0, D3 and D7 (+ D15 if halo detected at D7) after initiation of corticosteroid therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Doppler Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with GCA AND temporal artery Doppler WITH a halo sign on Day 0 of corticosteroid therapy and disappearing on Day 3.
Measured: 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
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.
Measured: On Day 3, Day 7 and Day 15 of corticosteroid therapy
Assessment of other vascular axes on Day 3
Number of patients with positive echo-Doppler signs of vasculitis in subclavian, axillary, common/external/internal carotid and vertebral arteries.
Measured: On Day 3 of corticosteroid therapy
Assessment of the number of patients with disappearance of the halo sign on Day 7
Measured: On Day 7 of corticosteroid therapy
Assessment of the number of patients with disappearance of the halo sign on Day 15
Measured: On Day 15 of corticosteroid therapy
Correlation between histological arteritis and echo-doppler halo sign
Number of patients with positive histology on temporal artery biopsy (to be performed at investigator's discretion)
Measured: On Day 0 of corticosteroid therapy
Correlation between C-reactive protein (CRP) kinetics and disappearance of the halo sign
Number of patients with positive C-reactive protein (CRP) on Day 3 and Day 7
Measured: On Day 3 and Day 7 of corticosteroid therapy
Correlation between corticosteroid dose and disappearance of halo sign
- Number of patients receiving methylprednisolone bolus
- Number of patients receiving prednisone equivalent greater than or equal to 60mg per day
Measured: From Day 0 to Day 15
Number of patients on Tocilizumab with disappearance of Halo sign on Day 15
Measured: On Day 15 of corticosteroid therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start27 Feb 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell Arteritis (GCA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single group is followed during 15 days with steroids treatment and the time until the halo disappears is monitored.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060274
- Sponsor's protocol ID
- CHM-2025/S06/02
- Acronym
- Halo-A
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No