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

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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

4 criteria

  • 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.
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Investigated drugs

[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.

What is already known about the treatment

[18F]fluor-PEG-folate – This medication is administered through a PET/CT scan, where it is used as a tracer to visualize certain biological processes in the body. Currently, it is being studied in clinical trials for its potential use in diagnosing giant cell arteritis, a condition that causes inflammation of the blood vessels. The main therapeutic indication is to assess the uptake of the tracer in the arteries of patients with active giant cell arteritis, both before and after standard treatment. At the molecular level, [18F]fluor-PEG-folate binds to folate receptors, which are often overexpressed in inflamed tissues, allowing for detailed imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514491-40-00Estimated enrolment10 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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