Giant Cell ArteritisSONIC-GCANCT05749094
Optic Nerve Sheath Ultrasound in Giant Cell Arteritis
An observational study of Giant Cell Arteritis and Anterior Ischemic Optic Neuropathy, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 7 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Giant Cell Arteritis, Anterior Ischemic Optic Neuropathy, Optic Neuropathy, Ischemic
- What is being tested?
- Optic nerve sheath ultrasound and Standardized GCA assessment
- How many people
- 285 participants
- Where
- 7 sitesCanada
- Study dates
- 9 Aug 2025to Mar 2029
- Phase
- Observational
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive participants referred for suspected new-onset GCA.
Who may be able to join
- To be included in SONIC-GCA, participants must meet all the following criteria:
- Age > 50 years.
- Referral to a GCA clinic for suspected, new-onset GCA.
- Ability to understand and willingness to sign an informed consent form.
- Willingness to comply with study visits and procedures.
Who cannot join
- An individual who meets any of these criteria will be excluded from SONIC-GCA:
- Referral for a suspected GCA relapse.
- 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.
- Current use of any conventional or biologic immunosuppressive therapy.
- 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.
- Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Canada7 sites, 7 recruiting
- Not yet recruiting
St-Joseph's Health Care London
London, Ontario, N6A 4V2
Lillian Barra, 519-646-6100, lillian.barra@sjhc.london.on.ca
- Not yet recruiting
MUHC - McGill University
Montreal, Quebec, H3G 1A4
Arielle Mendel, 4388556233, arielle.mendel@mcgill.ca
- Recruiting
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5
Jean-Paul Makhzoum, MD, MSc, jean-paul.makhzoum@umontreal.ca
Guylaine Marcotte, guylaine.marcotte.cnmtl@ssss.gouv.qc.ca
- Not yet recruiting
CIUSSS de l'Est-de-l'ile de Montreal
Montreal, Quebec, H4R 3K6
Roger Yang, 514-252-3400, roger.yang.med@ssss.gouv.qc.ca
- Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
Raymond Chu, 613-738-8400, rachu@toh.ca
- Not yet recruiting
CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, H1T 2M4
Patrick Liang, 819-346-1110, rhumatoens-med@USherbrooke.ca
- Not yet recruiting
Sinai Health - Toronto
Toronto, Ontario, M5G 1X5
Christian Pagnoux, 416-596-4200, Christian.pagnoux@sinaihealth.ca
About this study
Official title: 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:
- What is the performance of ONSD to identify patients with new-onset, active GCA?
- Is ONSD useful for monitoring GCA relapses during follow-up?
- What is the intra- and interobserver reliability of ONSD measurements?
- Does ONSD differ between patients with and without GCA-related retinal findings?
Read the detailed description
SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).
- Being tested
- Optic nerve sheath ultrasound, Standardized GCA assessment
- Medical subject headings
- Giant Cell Arteritis, Optic Neuropathy, Ischemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optic nerve sheath ultrasoundDiagnostic test
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.
Standardized GCA assessmentDiagnostic test
Clinical assesment, blood test review, temporal/axillary artery ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Optic nerve sheath ultrasound; Diagnostic Test: Standardized GCA assessment | |
| 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) Receives: Diagnostic Test: Optic nerve sheath ultrasound; Diagnostic Test: Standardized GCA assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of ONSD to identify new-onset GCA
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.
Measured: Baseline
ONSD in patients with and without GCA
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.
Measured: Baseline
Secondary outcomes (3)
ONSD changes over time
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.
Measured: Up to 2 years
The associations between ONSD changes and GCA relapses
The association between ONSD changes and GCA relapses will be assessed during the follow-up period, in patients with GCA.
Measured: Up to 2 years
Evaluation of the performance of ONSD to detect a GCA relapse
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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start9 Aug 2025
- Primary completionDec 2027 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Cell ArteritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Ciusss de L'Est de l'Île de Montréal, Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke, Mount Sinai Hospital, Canada, St. Joseph's Health Care London, Ottawa Hospital Research Institute
- Responsible party
- Principal investigator, Jean-Paul Makhzoum, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Jean-Paul Makhzoum, MD, Study chair, Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749094
- Sponsor's protocol ID
- 20201890
- Acronym
- SONIC-GCA
- Status last verified
- Oct 2026
- First submitted
- 18 Feb 2023
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sonographic Assessment of the Optic Nerve Sheath in Giant Cell Arteritis
- ClinicalTrials.gov ID
- NCT05749094
- Acronym / sponsor ID
- SONIC-GCA / 20201890
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre, Ciusss de L'Est de l'Île de Montréal, Estrie University Integrated Health and Social Services Center - University Hospital of Sherbrooke, Mount Sinai Hospital, Canada, St. Joseph's Health Care London, Ottawa Hospital Research Institute
- Study start
- 9 Aug 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 1 Mar 2023 (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 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:
- What is the performance of ONSD to identify patients with new-onset, active GCA?
- Is ONSD useful for monitoring GCA relapses during follow-up?
- What is the intra- and interobserver reliability of ONSD measurements?
- Does ONSD differ between patients with and without GCA-related retinal findings?
Detailed description
SONIC-GCA is a prospective cohort and validation study conducted in centers of the Canadian Vasculitis Research Network (CanVasc).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GCA group | – | Diagnostic Test: Optic nerve sheath ultrasound, Diagnostic Test: Standardized GCA assessmentAscertainment 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) |
| Non-GCA group | – | Diagnostic Test: Optic nerve sheath ultrasound, Diagnostic Test: Standardized GCA assessmentParticipants who do not meet the composite clinical test validation for GCA (above). Study visits : Baseline and Month 6 (phone follow-up) |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive participants referred for suspected new-onset GCA.
Key inclusion criteria (5 listed)
- Age > 50 years.
- Referral to a GCA clinic for suspected, new-onset GCA.
- Ability to understand and willingness to sign an informed consent form.
- Willingness to comply with study visits and procedures.
Key exclusion criteria (6 listed)
- Referral for a suspected GCA relapse.
- 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.
- Current use of any conventional or biologic immunosuppressive therapy.
- 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.
- Any condition that impairs the ability to perform optic nerve sheath ultrasound or fundoscopy.
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 |
|---|---|---|
| Optic nerve sheath ultrasoundThe 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 | GCA group, Non-GCA group |
| Standardized GCA assessmentClinical assesment, blood test review, temporal/axillary artery ultrasound | Diagnostic test | GCA group, Non-GCA group |
Primary outcome
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.
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.
3 secondary outcomes
ONSD changes over time
Time frame: Up to 2 years
The associations between ONSD changes and GCA relapses
Time frame: Up to 2 years
Evaluation of the performance of ONSD to detect a GCA relapse
Time frame: Up to 2 years
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 21 Oct 2026.
- Vasculitis Clinic - University of MontrealLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jean-Paul Makhzoum, MD study chair
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal, University of Montreal
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Giant Cell Arteritis and Anterior Ischemic Optic Neuropathy, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 7 sites in Canada.
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 5 inclusion and 6 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. 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 Jean-Paul Makhzoum, MD (5143382222 ext. 2725, jean-paul.makhzoum@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of ONSD to identify new-onset GCA (time frame: Baseline). The study lists 2 primary outcomes in all. 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 21 Oct 2026.