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Study Using Gallium-68 FAPI PET/MRI Imaging to Measure Disease Activity in Patients with Graves' Eye Disease

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study examines Graves' orbitopathy, a condition that affects the eyes and tissues around them, causing symptoms such as swelling, bulging of the eyes, and discomfort. This condition is related to problems with the thyroid gland and can vary in how active or severe it is over time. The study will use a substance called 68Ga-FAPI-46, which is a solution for injection that helps make certain cells visible during imaging scans. This substance attaches to proteins that are active in areas of inflammation and tissue changes, allowing doctors to see these areas more clearly.

The purpose of the study is to compare how much of the imaging substance is taken up by the tissues around the eyes in patients who have active disease versus those who have inactive disease. Active disease means the condition is currently causing noticeable symptoms and changes, while inactive disease means the condition has been stable and quiet for at least six months. The study will involve patients receiving an injection of the imaging substance and then undergoing a PET scan combined with an MRI scan. A PET scan is a type of imaging that shows how tissues and organs are functioning by detecting the injected substance, while an MRI scan uses magnetic fields to create detailed pictures of the body's internal structures.

During the study, researchers will examine the scan images to see how much of the substance accumulates in the eye tissues of patients with active disease compared to those with inactive disease. They will also look at how the scan results relate to other measurements such as swelling seen on the MRI, the symptoms patients are experiencing, and laboratory test results. This information may help doctors better understand and assess the activity level of the disease in future patients.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial screening and enrollment
Your eligibility for this study will be assessed based on your diagnosis of Graves' orbitopathy, which is an eye condition associated with thyroid disease.
Your disease activity will be evaluated using a Clinical Activity Score, which is a measurement system that helps determine how active your eye condition is at the moment.
If your Clinical Activity Score is greater than 3, you will be classified as having active disease. If your score has been 0 or 1 for at least 6 months after previously having a score greater than 3, you will be classified as having inactive disease.
Step 2
Pre-imaging assessment
Before the imaging procedure, your clinical symptoms will be documented.
Laboratory blood tests will be performed to record current values related to your condition.
These measurements will later be compared with the imaging results.
Step 3
PET-MRI imaging procedure
You will receive an injection of the study medication called 68Ga-FAPI-46.
This medication is a solution for injection that will be administered intravenously, meaning it will be injected directly into a vein.
The medication contains a radioactive tracer that binds to specific proteins called fibroblast activation proteins, which are present in areas of active inflammation.
After the injection, you will undergo a PET-MRI scan, which is a combined imaging technique that uses both positron emission tomography and magnetic resonance imaging to create detailed pictures of your eye area.
The scan will measure how much of the injected tracer accumulates in your eye tissues, which helps assess the level of disease activity.
Step 4
Image analysis and comparison
The images obtained from your scan will be analyzed to measure the uptake of the tracer in your eye tissues.
The MRI results will be evaluated for signs of edema, which refers to swelling caused by fluid accumulation in the tissues around your eyes.
Your imaging results will be compared with your clinical symptoms and laboratory values to understand the relationship between these different measurements.
The tracer uptake patterns will help determine whether your disease is in an active or inactive phase.
Step 5
Study completion
After the imaging procedure and analysis are complete, your participation in this study will be finished.
The study is expected to run from November 2025 until March 2026.
The information collected will be used to evaluate whether this imaging technique can effectively distinguish between active and inactive disease in patients with Graves' orbitopathy.

Who can join the trial?

5 criteria

You must have Graves' Orbitopathy, which is an eye condition related to thyroid problems that can cause swelling and bulging of the eyes
You must have active Graves' Orbitopathy with a Clinical Activity Score greater than 3, meaning your eye condition is currently causing symptoms like redness, swelling, or pain
OR you must have inactive Graves' Orbitopathy, meaning you previously had active disease with a score greater than 3, but your current score has been 0 or 1 for at least 6 months, showing your condition is now quiet
You can be male or female
You must be an adult or elderly person

Who cannot join the trial?

9 criteria

Pregnancy or breastfeeding: Women who are pregnant or nursing a baby cannot participate in this study
Previous allergic reactions: You cannot join if you have had an allergic reaction to FAPI (a special imaging substance used to see active areas in the body) or similar substances in the past
Kidney problems: People with severe kidney disease or poor kidney function cannot take part, as the body needs healthy kidneys to remove the imaging substance
Recent imaging tests: You cannot participate if you have had certain imaging tests using radioactive substances within a specific time period before this study
Other active cancers: People who currently have cancer or have had cancer recently cannot join this study
Inability to lie still: You cannot participate if you are unable to lie flat and stay still for the time needed to complete the imaging scan
Severe claustrophobia: People with extreme fear of enclosed spaces who cannot tolerate being in the scanning machine are excluded
Other serious medical conditions: You cannot join if you have other severe illnesses that would make it unsafe for you to participate in the study
Unwillingness to follow study procedures: You must be willing and able to follow all study requirements and attend all scheduled visits

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Verified sites

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Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands

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Investigated drugs

[68Ga]Ga-FAPI is a radioactive tracer used in imaging scans to help doctors see areas of disease activity in the body. In this study, it is being used with PET/MRI scanning technology to examine patients with Graves' orbitopathy, which is an eye condition. The tracer works by attaching to activated fibroblasts, which are cells involved in inflammation and tissue changes. By showing where these active cells are located, the scan can help doctors determine whether the eye disease is currently active or inactive.

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

What is already known about the treatment

[68Ga]Ga-FAPI – This is a radioactive imaging agent administered through injection into a vein, used in combination with PET/MRI scanning technology to create detailed pictures of the body. It is currently being studied in clinical trials to evaluate its potential use in detecting and measuring disease activity in patients with Graves' orbitopathy, an eye condition associated with thyroid problems. The medication works by attaching to a specific protein called fibroblast activation protein, which becomes more active in areas of inflammation and tissue remodeling, allowing doctors to see where the disease is most active. This substance belongs to a class of diagnostic radiopharmaceuticals, which are medications containing small amounts of radioactive materials used to help visualize organs and tissues during medical imaging procedures.

Investigated diseases

Graves' Orbitopathy – Graves' Orbitopathy is an eye condition that occurs when the immune system mistakenly attacks the tissues and muscles around the eyes. The disease causes inflammation and swelling of the tissues behind the eyeballs, which can push the eyes forward and make them appear bulging. It often develops in people who have or had an overactive thyroid gland, though it can occur independently. The condition can affect one or both eyes and may cause double vision, eye pain, redness, and difficulty moving the eyes. The disease progresses through an active phase where inflammation is present and symptoms worsen, followed by an inactive phase where the inflammation subsides but some changes may remain. During the active phase, the swelling and inflammation can lead to increased pressure behind the eyes and changes in the eye muscles.