oPtic Nerve Sheath Evaluation in gianT Cell aRtheritis by UltraSound

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-04

Study Completion Date

2028-03-31

Brief Summary

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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

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Detailed Description

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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

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Giant Cell Arteritis (GCA)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Orbital ultrasounds

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.

Group Type EXPERIMENTAL

orbital ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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orbital ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Omar AL TABAA, Dr

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

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