Giant Cell Arteritis (GCA)PETRUSNCT07001059
oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
A study testing orbital ultrasound in people with Giant Cell Arteritis (GCA), run by Hôpital NOVO at 9 sites in France.
Trial summary
The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Giant Cell Arteritis (GCA)
- What is being tested?
- orbital ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 9 sitesFrance
- Study dates
- 4 Sep 2025to 31 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient with suspected GCA
- Patient over 50 years
Who cannot join
- Patient with history of GCA
- Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan
- Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension
- Use of corticosteroids > 0.5mg/kg in the last 2 weeks
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Not yet recruiting
Rhumatology departement - Centre Hospitalier Aix en Provence
Aix-en-Provence
François VIDAL, Dr, +33442335049, fvidal@ch-aix.fr
- Not yet recruiting
Rhumatology department - Centre Hospitalier Universitaire de Brest
Brest
Baptiste QUERE, Dr, +33 2 98 22 33 33, baptiste.quere@chu-brest.fr
- Recruiting
Internal Medecine Department- CHU Caen
Caen
Jonathan BOUTEMY, Dr, +33231064579, boutemy-j@chu-caen.fr
- Not yet recruiting
Internal Medicine and Clinical Immulogy department - Centre Hospitalier Universitaire de Dijon
Dijon
Maxime SAMSON, Dr, +33 3 80 29 34 32, maxime.samson@chu-dijon.fr
- Not yet recruiting
Internal Medicine and VascularMedecine Department - Centre Hospitalier Universitaire de Nantes
Nantes
Olivier ESPITIA, Dr, +33 2 40 08 33 55, Olivier.ESPITIA@chu-nantes.fr
- Not yet recruiting
Internal Medicine department - Hôpital Saint-Antoine
Paris
Etienne GHRENASSIA, Dr, +33 1 71 97 05 06, etienne.ghrenassia@aphp.fr
- Not yet recruiting
Rhumatology department - Hôpital Bichat
Paris
Sébastien OTTAVIANI, Dr, +33 1 40 25 70 27, sebastien.ottaviani@aphp.fr
- Not yet recruiting
Rhumatology department - Hôpital NOVO - Pontoise site
Pontoise
Omar AL TABAA, Dr, +33130755226, omar.altabaa@ght-novo.fr
- Not yet recruiting
Rhumatology department - Centre Hospitalier Universitaire de Tours
Tours
Guillaume CARVAJAL, Dr, +33 2 47 47 47 47, guillermo.carvajal@univ-tours.fr
About this study
The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis
Read the detailed description
Giant Cell Arteritis (GCA) is a vasculitis affecting large and medium-sized vessels. It predominantly occurs in women, with a sex ratio of 3:1, and mainly affects individuals around 70 years of age. GCA is a rare condition, with an incidence of approximately 10 cases per 100,000 people in France.
Current recommendations suggest using imaging techniques and/or temporal artery biopsy (TAB) based on the clinical resources available. The key challenge in suspected cases of GCA is to establish a rapid diagnosis.
It is important to note that false-negative imaging results may occur if corticosteroid treatment is initiated prior to imaging: after 3 days for PET-CT, 5 to 7 days for Doppler ultrasound, and up to 14 days for TAB.
Diagnosing GCA is not always easy and depends on depends on the prompt performance of complementary examinations. Studies have shown that the optic nerve sheath is thickened on ultrasound in patients with GCA. In this context, the investigator aims to evaluate the measurement of the optic nerve sheath via ultrasound for diagnosing GCA. Ultrasound offers a faster, non-invasive, widely available, and cost-effective diagnostic tool.
- Conditions
- Giant Cell Arteritis (GCA)
- Being tested
- orbital ultrasound
- Keywords
- Giant Cell Arteritis, Optic nerve sheath, Ultrasound
- 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.
orbital ultrasoundDiagnostic test
orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.
| Study group | Role | What they receive |
|---|---|---|
| Orbital ultrasounds | Experimental | Orbital ultrasounds on patients suspected of GCA at the enrollment (M0) and at 6 months if the suspicion of GCA is confirmed after all the tests realized at the enrollment. Receives: Diagnostic Test: orbital ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)
Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard.
The clinical expert's evaluation will be blinded to the optic nerve sheath measurements.
Measured: At the patient enrollment visit and at 6 months
Secondary outcomes (8)
Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.
Mean bias according to Bland-Altman analysis, limits of agreement with their confidence intervals, maximum acceptable difference (clinical and statistical difference calculated using the root sum of squares of the coefficients of variation), inter-rater ICC.
Measured: At the patient enrollment visit and at 6 months
Evaluate the diagnostic performance of ONSD in GCA.
Sensitivity, specificity, ROC curve inflection point (pathological threshold value), positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio.
Measured: At the patient enrollment visit and at 6 months
Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.
Measurement of the optic nerve sheath diameter (ONSD) by ultrasound at baseline (within 3 days of corticosteroid initiation) in all patients, and at 6 months in patients with GCA.
Measured: At the patient enrollment visit and at 6 months
Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.
Comparison of mean ONSD between subgroups: cranial GCA, extracranial GCA, and GCA-negative patients.
Measured: At the patient enrollment visit and at 6 months
Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement.
Comparison of mean ONSD between subgroups: GCA with visual involvement, GCA without visual involvement, and GCA-negative patients
Measured: At the patient enrollment visit and at 6 months
Assess the feasibility of ultrasound as a diagnostic tool for GCA.
Description of the patient flow : average duration of the exam
Measured: At the patient enrollment visit and at 6 months
Assess the feasibility of ultrasound as a diagnostic tool for GCA.
Description of the patient flow : percentage of exams performed, and percentage of interpretable exams.
Measured: At the patient enrollment visit and at 6 months
Assess the feasibility of ultrasound as a diagnostic tool for GCA.
Description of the patient flow : number of exams performed, and number of interpretable exams.
Measured: At the patient enrollment visit and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start4 Sep 2025
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Mar 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
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Omar AL TABAA, Dr, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001059
- Sponsor's protocol ID
- CHRD 0524
- Other IDs
- 2025-A00141-48
- Acronym
- PETRUS
- Status last verified
- Sep 2025
- First submitted
- 22 May 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound
- ClinicalTrials.gov ID
- NCT07001059
- Acronym / sponsor ID
- PETRUS / CHRD 0524
- Conditions
- Giant Cell Arteritis (GCA)
- Keywords
- Giant Cell Arteritis, Optic nerve sheath, Ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 4 Sep 2025 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether the measure of the optic nerve sheath is a reliable diagnostic marker for giant cell arteritis
Detailed description
Giant Cell Arteritis (GCA) is a vasculitis affecting large and medium-sized vessels. It predominantly occurs in women, with a sex ratio of 3:1, and mainly affects individuals around 70 years of age. GCA is a rare condition, with an incidence of approximately 10 cases per 100,000 people in France.
Current recommendations suggest using imaging techniques and/or temporal artery biopsy (TAB) based on the clinical resources available. The key challenge in suspected cases of GCA is to establish a rapid diagnosis.
It is important to note that false-negative imaging results may occur if corticosteroid treatment is initiated prior to imaging: after 3 days for PET-CT, 5 to 7 days for Doppler ultrasound, and up to 14 days for TAB.
Diagnosing GCA is not always easy and depends on depends on the prompt performance of complementary examinations. Studies have shown that the optic nerve sheath is thickened on ultrasound in patients with GCA. In this context, the investigator aims to evaluate the measurement of the optic nerve sheath via ultrasound for diagnosing GCA. Ultrasound offers a faster, non-invasive, widely available, and cost-effective diagnostic tool.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Orbital ultrasounds | Experimental | Diagnostic Test: orbital ultrasoundOrbital ultrasounds on patients suspected of GCA at the enrollment (M0) and at 6 months if the suspicion of GCA is confirmed after all the tests realized at the enrollment. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient with suspected GCA
- Patient over 50 years
Key exclusion criteria (4 listed)
- Patient with history of GCA
- Patient with a history of polymyalgia rheumatic (PMR) without initial PET scan
- Patient with a history of retinal disease, demyelinating disease, or intracranial hypertension
- Use of corticosteroids > 0.5mg/kg in the last 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orbital ultrasoundorbital ultrasound at the beginning of the participation, and at 6 months after the inclusion. | Diagnostic test | Orbital ultrasounds |
Primary outcome
Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA)
Time frame: At the patient enrollment visit and at 6 months
Area under the ROC curve (AUC) of the optic nerve sheath measurements obtained by ultrasound during the enrollment phase, using the final clinical expert diagnosis at 6 months as the reference standard. The clinical expert's evaluation will be blinded to the optic nerve sheath measurements.
8 secondary outcomes
Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.
Time frame: At the patient enrollment visit and at 6 months
Evaluate the diagnostic performance of ONSD in GCA.
Time frame: At the patient enrollment visit and at 6 months
Study the evolution of ONSD under treatment between M0 and M6 in patients with GCA.
Time frame: At the patient enrollment visit and at 6 months
Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.
Time frame: At the patient enrollment visit and at 6 months
Exploratory evaluation of ONSD based on the presence or absence of GCA with visual involvement.
Time frame: At the patient enrollment visit and at 6 months
Assess the feasibility of ultrasound as a diagnostic tool for GCA.
Time frame: At the patient enrollment visit and at 6 months
Assess the feasibility of ultrasound as a diagnostic tool for GCA.
Time frame: At the patient enrollment visit and at 6 months
Assess the feasibility of ultrasound as a diagnostic tool for GCA.
Time frame: At the patient enrollment visit and at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Omar AL TABAA, Dr principal investigator
Hôpital NOVO
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orbital ultrasound in people with Giant Cell Arteritis (GCA), run by Hôpital NOVO at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline DELATTRE (+330130754131, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess whether the Optic Nerve Sheath Diameter (ONSD) measured by orbital ultrasound serves as an effective diagnostic marker for Giant Cell Arteritis (GCA) (time frame: At the patient enrollment visit and at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.