RecruitingOBSERVATIONAL

Optic Nerve Sheath Ultrasound in Giant Cell Arteritis

This study, called SONIC-GCA, is investigating a new way to help diagnose and monitor a condition called Giant Cell Arteritis (GCA). GCA is an inflammation of blood vessels, often affecting those around the head and eyes. We're looking at whether a simple ultrasound scan, specifically measuring the thickness of the optic nerve sheath (the covering of the main nerve behind your eye), can effectively identify people with new GCA. We also want to see if this scan can help track if the condition flares up again after treatment. The study will check how consistent these measurements are and if they differ in people with eye problems related to GCA. We hope this could lead to a quicker, safer way to help manage GCA.

At a glance

Status

Recruiting

Sponsor

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

Enrolment target

285

Start

01 Aug 2025

Estimated completion

01 Mar 2029

Giant Cell Arteritis Anterior Ischemic Optic Neuropathy Optic Neuropathy, Ischemic

What is this study about?

Giant Cell Arteritis (GCA) is a condition where the blood vessels, often those in the head, become inflamed. This can cause headaches, jaw pain, and importantly, can sometimes affect your eyesight. Diagnosing GCA can sometimes be tricky and involves several tests. This study is exploring a new way to help with this: using a simple ultrasound scan of the eye.

Imagine the main nerve that connects your eye to your brain, called the optic nerve. This nerve has a protective covering, or 'sheath'. In this study, we are using a special ultrasound machine, similar to those used to look at babies, to measure the thickness of this covering. We want to see if this measurement can help doctors tell if someone has newly developed GCA, and also if it can show when the condition is flaring up again.

The SONIC-GCA study aims to answer a few key questions. For example, how good is this ultrasound measurement at finding GCA in new patients? Can it help doctors know if the GCA is getting worse or better during treatment? We also want to make sure the measurements are reliable, no matter who is doing the scan, and see how the measurements compare between people with and without eye problems from GCA. If successful, this could offer a valuable, non-invasive tool to help manage GCA.

Key takeaways

This study is testing a new ultrasound scan for GCA.
It aims to simplify how doctors diagnose and monitor GCA.
It involves a gentle scan of the nerve behind your eye.
You must be aged 50 or over and newly suspected of having GCA.
Participation involves regular clinic visits and assessments.

Who may be eligible?

This study is looking for people aged 50 and over who have recently been referred to a specialist clinic because their doctor suspects they might have a new case of Giant Cell Arteritis (GCA).

To join, you need to understand what the study involves and be happy to sign a consent form. You also need to be willing to come for study visits and follow the procedures. We can't include people who are already being treated for a GCA flare-up, or those who have been on certain steroid or immune-suppressing medications for a while recently.

We also can't include people who have a known history of certain eye, nerve, or brain conditions, or any health issues that would make it difficult to perform the ultrasound scan or examine the back of your eye.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 50 years old or older?
Has your doctor recently suggested you might have new GCA?
Are you able to agree to take part after understanding the study?
Are you willing to attend study visits and follow the plan?
Have you *not* been on specific steroid medicines for a while recently?
Do you *not* have certain pre-existing eye, nerve, or brain conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a series of assessments. This would include the special ultrasound scan of your optic nerve sheath. You would also have standard check-ups and assessments that are usually done when diagnosing and monitoring GCA. The study involves regular visits to the clinic, and our team will guide you through each step.

The study does not involve new medication. Instead, it focuses on testing a new assessment method (the ultrasound). We will be monitoring your condition over time to see how the ultrasound results compare with your GCA status. The exact number of visits and the total duration of your participation will be explained in detail by the study team, but it will involve follow-up appointments.

Potential risks and benefits

Taking part in this study could help us learn more about GCA, potentially leading to better diagnostic methods in the future. The ultrasound scan itself is a common, non-invasive procedure, similar to scans used in pregnancy, and is generally considered very safe with no known risks from the ultrasound waves. However, as with any clinic visit, there may be a small amount of time and travel involved. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

St-Joseph's Health Care London
Verified postcode
London, Canada· Not yet recruiting
Sinai Health - Toronto
Verified postcode
Toronto, Canada· Not yet recruiting
MUHC - McGill University
Verified postcode
Montreal, Canada· Not yet recruiting
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Verified postcode
Montreal, Canada· Recruiting
CIUSSS de l'Est-de-l'ile de Montreal
Verified postcode
Montreal, Canada· Not yet recruiting
CIUSSS de l'Estrie - CHUS
Verified postcode
Sherbrooke, Canada· Not yet recruiting

Common questions

What is Giant Cell Arteritis?

It's a condition where blood vessels, usually in the head, become inflamed. It can cause serious problems, including vision loss, if not treated.

What is an optic nerve sheath ultrasound?

It's a painless scan using sound waves to measure the thickness of the protective covering around the main nerve behind your eye.

Will I receive new medicine in this study?

No, this study is looking at an assessment method (the ultrasound), not new medication. Your treatment for GCA will be managed by your doctors as usual.

How long will I be in the study?

The exact duration and number of visits will be explained by the study team, but it will involve some follow-up appointments to monitor your condition.

Can I stop participating if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.

How to find out more

Jean-Paul Makhzoum, MD

jean-paul.makhzoum@umontreal.ca 5143382222 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.