Optic Nerve Sheath Ultrasound in Giant Cell Arteritis (SONIC-GCA)

August 2, 2025 updated by: Jean-Paul Makhzoum, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis

The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis (SONIC-GCA) study will evaluate the performance of the optic nerve sheath diameter (ONSD), measured via ultrasound, to diagnose and monitor GCA. SONIC-GCA builds upon our previous pilot studies and will answer the following questions:

  1. What is the performance of ONSD to identify patients with new-onset, active GCA?
  2. Is ONSD useful for monitoring GCA relapses during follow-up?
  3. What is the intra- and interobserver reliability of ONSD measurements?
  4. Does ONSD differ between patients with and without GCA-related retinal findings?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).

Study Type

Observational

Enrollment (Estimated)

285

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4V2
      • Toronto, Ontario, Canada, M5G 1X5
    • Quebec
      • Montreal, Quebec, Canada, H4J1C5
      • Montréal, Quebec, Canada, H3G 1A4
        • Not yet recruiting
        • MUHC - McGill University
        • Contact:
      • Montréal, Quebec, Canada, H4R 3K6
      • Sherbrooke, Quebec, Canada, H1T 2M4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive participants referred for suspected new-onset GCA.

Description

Our population of interest is patients referred from any settings for suspected, new-onset GCA.

Inclusion criteria:

To be included in SONIC-GCA, participants must meet all the following criteria:

  1. Age > 50 years.
  2. Referral to a GCA clinic for suspected, new-onset GCA.
  3. Ability to understand and willingness to sign an informed consent form.
  4. Willingness to comply with study visits and procedures.

Exclusion criteria:

An individual who meets any of these criteria will be excluded from SONIC-GCA:

  1. Referral for a suspected GCA relapse.
  2. Current use of systemic glucocorticoids, with the following duration at the baseline visit: ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days.
  3. Current use of any conventional or biologic immunosuppressive therapy.
  4. Known previous medical history of retinal diseases, optic nerve diseases, demyelinating diseases, normotensive hydrocephalus, intracranial tumors (benign or malignant), or any conditions associated with intracranial hypertension.
  5. Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GCA group

Ascertainment of GCA will occur 6 months after study inclusion and will require all the following features: 1) initial symptoms and clinical evolution consistent with GCA; 2) at least one positive diagnostic test for GCA, including ultrasound of temporal arteries, temporal artery biopsy, cranial MRI or cranial PET; and 3) satisfies the 2022 ACR-EULAR classification criteria for GCA.

Study visits :

Baseline - Month 3, 6, 12, 18 and 24 + relapse visit (if applicable)
Diagnostic test: Optic nerve sheath ultrasound
The patients are examined in a supine relaxed position. The probe is gently placed on the closed eyelid with a standard ultrasound gel and adjusted to a suitable angle to display the optic nerve entry into the eyeball. Measurements are done 3mm distal to the posterior aspect of the ocular globe. Ultrasosonographic 14L5 probe is used with a safe thermal index, mechanical index and intensity limit. All patients will also undergo a bedside fundoscopic examination. Official ophthalmology consultation will be requested in patients with visual symptoms or abnormal fundoscopy.
Diagnostic test: Standardized GCA assessment
Clinical assesment, blood test review, temporal/axillary artery ultrasound
Non-GCA group

Participants who do not meet the composite clinical test validation for GCA (above).

Study visits : Baseline and Month 6 (phone follow-up)
Diagnostic test: Optic nerve sheath ultrasound
The patients are examined in a supine relaxed position. The probe is gently placed on the closed eyelid with a standard ultrasound gel and adjusted to a suitable angle to display the optic nerve entry into the eyeball. Measurements are done 3mm distal to the posterior aspect of the ocular globe. Ultrasosonographic 14L5 probe is used with a safe thermal index, mechanical index and intensity limit. All patients will also undergo a bedside fundoscopic examination. Official ophthalmology consultation will be requested in patients with visual symptoms or abnormal fundoscopy.
Diagnostic test: Standardized GCA assessment
Clinical assesment, blood test review, temporal/axillary artery ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of ONSD to identify new-onset GCA
Time Frame: Baseline
The primary outcome of SONIC-GCA is to determine the optimal ONSD cutoff for identifying GCA at the baseline visit and to assess its diagnostic performance, including sensitivity, specificity, positive and negative predictive values, and accuracy.
Baseline
ONSD in patients with and without GCA
Time Frame: Baseline
At baseline, ONSD measurements (in mm) of the left and right eyes of each participant will be recorded and used to calculate the mean ONSD for patients with and without GCA.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ONSD changes over time
Time Frame: Up to 2 years
The main secondary outcome will determine whether ONSD dynamically correlates with relapse risk over the follow-up period in patients with GCA, providing insight into its potential as a biomarker for disease monitoring.
Up to 2 years
The associations between ONSD changes and GCA relapses
Time Frame: Up to 2 years
The association between ONSD changes and GCA relapses will be assessed during the follow-up period, in patients with GCA.
Up to 2 years
Evaluation of the performance of ONSD to detect a GCA relapse
Time Frame: Up to 2 years
We will assess the diagnostic performance of the initial ONSD cutoff (from the primary objective) at each follow-up visit to differentiate between relapse and remission. This analysis will determine whether the established cutoff remains a reliable marker for monitoring disease status in GCA over time.
Up to 2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra- and Inter- observer reliability
Time Frame: Baseline
Intra- and interobserver reliability of ONSD measurements
Baseline
Association between ONSD and Retinal Changes
Time Frame: Up to 2 years
The association between ONSD and the presence/absence of GCA-related retinal findings on digital fundoscopy in patients with GCA.
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre
Ottawa Hospital Research Institute
Mount Sinai Hospital, Canada
St. Joseph's Health Care London
Ciusss de L'Est de l'Île de Montréal
Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke

Investigators

  • Study Chair: Jean-Paul Makhzoum, MD, Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 18, 2023

First Submitted That Met QC Criteria

February 18, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 7, 2025

Last Update Submitted That Met QC Criteria

August 2, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201890

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Optic Neuropathy, Ischemic

Clinical Trials on Optic nerve sheath ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe