orbital ultrasound
Diagnostic Testorbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.
NCT Number: NCT07001059
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
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Rhumatology departement - Centre Hospitalier Aix en Provence, Aix-en-Provence, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
orbital ultrasound at the beginning of the participation, and at 6 months after the inclusion.
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.
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.
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.
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.
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.
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
Time frame: At the patient enrollment visit and at 6 months
Description of the patient flow : average duration of the exam
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.
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.
Contact information is provided by the study sponsor or research team.
Hôpital NOVO
Other
Acronym: PETRUS
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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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