AuthorisedPhase I and Phase II (Integrated)- OtherInterventional

The use of [68Ga]Ga-FAPI PET/MRI in assessing disease activity in patients with Graves’ orbitopathy

This research study is investigating a new type of scan called a PET/MRI using a special tracer called Ga-FAPI. This scan is being tested in people who have Graves' orbitopathy, an eye condition linked to an overactive thyroid. Doctors want to see if this new scan can accurately show how active the eye disease is, helping them distinguish between actively inflamed eyes and those that are stable. The study aims to compare the results of the scan with other medical information like MRI scans, symptoms you experience, and blood test results. This could potentially lead to better ways for doctors to tell how severe your condition is and decide on the best treatment.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

30 Oct 2025

Graves' Orbitopathy

What is this study about?

This study is focused on a health condition called Graves' orbitopathy, which is an eye problem that can happen to people with an overactive thyroid gland. It often causes inflammation and swelling around the eyes. Doctors sometimes find it tricky to know exactly how active the disease is – meaning whether it's currently inflamed and getting worse, or if it's stable and not changing.

This research is testing a special kind of body scan called a PET/MRI. It uses a substance called Ga-FAPI, which is given to you before the scan. This substance helps the scan highlight areas of inflammation. The main goal is to see if this scan can clearly show the difference between eyes that are actively inflamed and those that are not. If it can, this scan could become a very useful tool for doctors.

Ultimately, researchers hope that this new scanning method will give doctors a clearer picture of how active your Graves' orbitopathy is. This information, combined with other tests like regular MRI scans, your symptoms, and blood tests, could help doctors make more informed decisions about your care and treatment plans. It's about finding better ways to understand and manage your condition.

Key takeaways

This study is testing a new scan for Graves' orbitopathy.
It aims to see how active the eye condition is.
The scan uses a special substance called Ga-FAPI.
Open to adults aged 18 and over, both men and women.
The goal is to improve understanding and management of the condition.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults can also participate. Both men and women are welcome to join.

Essentially, the study is open to any adult who has been diagnosed with Graves' orbitopathy. The researchers are looking for people whose condition varies, some might have active inflammation, and others might have a more stable form of the disease.

More specific details about your health and medical history would be discussed with the study team to confirm if this trial is right for you.

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 18 years old or older?
Do you have Graves' orbitopathy?
Are you able to attend appointments at the study site?
Are you willing to have a PET/MRI scan?
Are you happy to have blood tests and other assessments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would undergo a special scan called a PET/MRI. This scan involves receiving a small amount of a substance called Ga-FAPI, which is given to you before the scan itself. The scan helps doctors see what's happening inside your body, particularly around your eyes. You would also likely have other assessments, such as standard MRI scans, discussions about your symptoms, and possibly blood tests to check various levels. The research team would explain each step in detail. The total duration of your involvement and number of visits would depend on the study's specific schedule, but generally, these types of imaging studies involve a visit for the scan and any associated tests.

Potential risks and benefits

Potential benefits of participating include helping doctors learn more about Graves' orbitopathy, which could improve care for others in the future. You might also gain a more detailed understanding of your own condition through the scans and tests. Potential risks are generally low for imaging studies, but could include minor discomfort from injections or a very small exposure to radiation from the PET scan, similar to doses in other common medical imaging tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is Graves' orbitopathy?

It's an eye condition sometimes seen with an overactive thyroid, causing inflammation and changes around the eyes. It's also known as thyroid eye disease.

What is a PET/MRI scan?

It's a special type of body scan that combines two different imaging techniques to give doctors a very detailed picture of what's happening inside your body.

What is Ga-FAPI?

It's a special tracer, a substance given before the scan, that helps highlight areas of inflammation or active disease, making them easier to see on the PET/MRI. It's not a treatment.

Will this scan treat my condition?

No, this study is for research and diagnosis, not treatment. The scan helps doctors understand your condition better, but it won't directly treat your Graves' orbitopathy.

How long will I be involved in the study?

The study aims to see how well the scan works. Your involvement would likely include one or more visits for the scan and related tests, but the research team will give you a detailed schedule.