An interventional study of Doppler Ultrasound in Giant Cell Arteritis (GCA) and Doppler Ultrasound, sponsored by Centre Hospitalier le Mans. Recruiting at 6 sites in France. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by Centre Hospitalier le Mans · Not applicable, Interventional, and Diagnostic
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.
147 studies on the registry are indexed under Giant Cell Arteritis; 49 are open to participants now.
This study's planned enrollment of 64 is close to the median of 64 across 65 interventional studies indexed under Giant Cell Arteritis.
Browse Giant Cell Arteritis studies →Centre Hospitalier le Mans is the lead sponsor of 44 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Doppler ultrasound of temporal arteries at D0, D3 and D7 (+/- D15) after initiation of corticosteroid therapy.
Procedure: Doppler Ultrasound
Doppler ultrasound of temporal arteries at D0, D3 and D7 (+ D15 if halo detected at D7) after initiation of corticosteroid therapy.
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
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.
Time frame: 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.
Time frame: On Day 3 of corticosteroid therapy
Assessment of the number of patients with disappearance of the halo sign on Day 7
Time frame: On Day 7 of corticosteroid therapy
Assessment of the number of patients with disappearance of the halo sign on Day 15
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From Day 0 to Day 15
Number of patients on Tocilizumab with disappearance of Halo sign on Day 15
Time frame: On Day 15 of corticosteroid therapy
Started Feb 2026 (actual). Primary completion is estimated for Feb 2028, 24 months after the start.
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Centre Hospitalier le Mans