Study on [18F]Fluoro-PEG-Folate Imaging for Patients with Giant Cell Arteritis

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What is this study about?

This clinical trial focuses on studying a condition known as giant cell arteritis (GCA), which is a type of inflammation that affects the large blood vessels. The study will use a special imaging technique called PET/CT to observe how a substance called [18F]Fluor-PEG-Folate is taken up by the arteries in patients with active GCA. This substance is given as a solution for injection and helps to highlight areas of inflammation in the blood vessels during the imaging process.

The purpose of the study is to evaluate how the arteries absorb [18F]Fluor-PEG-Folate in patients who have active GCA and then again in the same patients after they have received standard treatment for nine months. This will help researchers understand how the disease and its treatment affect the blood vessels over time. The study will involve patients who are experiencing symptoms of GCA and will require them to undergo imaging at the start and end of the nine-month period.

Participants will receive an injection of [18F]Fluor-PEG-Folate and then undergo a PET/CT scan to capture images of their blood vessels. This process will be repeated after nine months of standard treatment to compare the results. The study aims to provide valuable insights into the effectiveness of current treatments for GCA and how they impact the condition of the blood vessels.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, blood test results such as erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels, and clinical symptoms related to giant cell arteritis (GCA).

Imaging tests, such as ultrasound or FDG-PET/CT, are performed to ensure findings are consistent with large vessel GCA.

2 first imaging session

The first imaging session involves a PET/CT scan using the [18F]fluor-PEG-folate solution. This is administered as an intravenous bolus injection.

The purpose of this scan is to evaluate the uptake of the solution in the arteries, which helps in assessing the activity of the disease.

3 standard treatment period

Following the initial imaging, a standard treatment for GCA is administered for a period of 9 months. The specific treatment regimen is determined by the healthcare provider based on individual patient needs.

4 second imaging session

After 9 months of standard treatment, a second PET/CT scan is conducted using the same [18F]fluor-PEG-folate solution.

This scan is used to compare the arterial uptake of the solution before and after the treatment period, providing insights into the effectiveness of the treatment.

5 completion of study

The study concludes with the analysis of the imaging results to evaluate the primary endpoint, which is the change in arterial uptake of the solution over the course of the study.

Who Can Join the Study?

Must be at least 50 years old when the disease started.
Must have an erythrocyte sedimentation rate (ESR) of 50 mm/hr or higher. ESR is a blood test that can show inflammation in the body.
Must have a C-reactive protein (CRP) level of 10 mg/L or higher. CRP is another blood test that indicates inflammation.
Must have symptoms of large vessel GCA, which can include:
- General symptoms like tiredness, fever, weight loss, or night sweats.
- Pain or discomfort in the limbs when moving.
- Symptoms of polymyalgia rheumatica, which means pain in the shoulder or hip area with stiffness in the morning.
Must have imaging results, like an ultrasound or FDG-PET/CT scan, that match large vessel GCA.
Must be able to attend study appointments and follow the study rules.
Must be able to understand and agree to the study, and must give consent before any study procedures begin.

Who Cannot Join the Study?

Patients who are not diagnosed with giant cell arteritis, a condition that causes inflammation of certain blood vessels.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who do not meet other specific health criteria set by the study.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Utmdeqkszmws Msmasun Crtnxzd Gnfurqaac	Groningen	The Netherlands
Awtzafjoy Ubj	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.01.2024

Trial locations

[18F]fluor-PEG-folate is a special imaging agent used in PET/CT scans. It helps doctors see how active the disease is in the arteries of patients with giant cell arteritis (GCA). This imaging agent is used to check the level of disease activity before and after treatment.

Investigated diseases:

Giant cell arteritis

Giant Cell Arteritis – Giant cell arteritis is an inflammatory disease affecting the large and medium-sized arteries, primarily in the head. It often causes headaches, scalp tenderness, jaw pain, and vision problems. The inflammation can lead to narrowing or blockage of the affected arteries, reducing blood flow. This condition is more common in older adults, particularly those over 50 years of age. Symptoms may develop gradually or suddenly and can vary in intensity. If untreated, it can lead to serious complications, including vision loss.

Trial ID:

2024-514491-40-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on [18F]Fluoro-PEG-Folate Imaging for Patients with Giant Cell Arteritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?