Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07001059

oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rhumatology departement - Centre Hospitalier Aix en Provence, Aix-en-Provence, France

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with suspected GCA
  • Patient over 50 years

Exclusion criteria

  • 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

Treatment and study plan

orbital ultrasound

Diagnostic Test

orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Assess the reproducibility of the optic nerve sheath diameter (ONSD) measurements by ultrasound.

    Time frame: At the patient enrollment visit and at 6 months

    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.

  2. Evaluate the diagnostic performance of ONSD in GCA.

    Time frame: At the patient enrollment visit and at 6 months

    Sensitivity, specificity, ROC curve inflection point (pathological threshold value), positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio.

  3. 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

    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.

  4. Exploratory evaluation of ONSD according to the presence or absence of extracranial GCA.

    Time frame: At the patient enrollment visit and at 6 months

    Comparison of mean ONSD between subgroups: cranial GCA, extracranial GCA, and GCA-negative patients.

  5. 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

    Comparison of mean ONSD between subgroups: GCA with visual involvement, GCA without visual involvement, and GCA-negative patients

  6. Assess the feasibility of ultrasound as a diagnostic tool for GCA.

    Time frame: At the patient enrollment visit and at 6 months

    Description of the patient flow : average duration of the exam

  7. Assess the feasibility of ultrasound as a diagnostic tool for GCA.

    Time frame: At the patient enrollment visit and at 6 months

    Description of the patient flow : percentage of exams performed, and percentage of interpretable exams.

  8. Assess the feasibility of ultrasound as a diagnostic tool for GCA.

    Time frame: At the patient enrollment visit and at 6 months

    Description of the patient flow : number of exams performed, and number of interpretable exams.

Study contacts

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

Maryline DELATTRE

CONTACT

[email protected]

+330130754131

Mathilde WLODARCZYK

CONTACT

[email protected]

+330130754040 ext. 7199

Sponsors and collaborators

Lead sponsor

Hôpital NOVO

Other

Registry information

Acronym: PETRUS

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 3, 2025
Registry last updated
Sep 12, 2025

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.

Published trials that share one or more normalized conditions with this study.