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Study of [18F]FAPI-74 PET/CT Imaging in Patients with Connective Tissue Disease at Risk of Lung Fibrosis

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 focuses on patients with connective tissue diseases who are at high risk of developing interstitial lung disease, a condition that causes scarring of the lung tissue. The research uses a special imaging substance called [18F]FAPI-74, which is given through an intravenous injection. This substance helps create detailed images of the lungs using a combination of PET/CT scanning.

The purpose of this research is to compare lung images between patients whose lung condition may worsen over time and those whose condition remains stable. The study will look at how the imaging substance spreads in different parts of the lungs and measure the level of lung tissue changes. The imaging procedure involves lying still while special cameras take pictures of the lungs.

The research also includes collecting blood samples and analyzing tiny particles called extracellular vesicles that can provide information about lung health. Some participants may need to undergo a procedure called bronchoalveolar lavage, where lung fluid is collected to study the lung environment in more detail. The total study duration for each participant includes initial testing and follow-up visits over a 12-month period.

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 medical imaging

    A high-resolution CT scan (detailed lung x-ray) will be performed to confirm the presence of lung tissue changes

    The scan must show that at least 10% of lung tissue is affected by interstitial changes

  2. Step 2

    FAPI PET/CT scan - first visit

    You will receive an injection of [18F]FAPI-74 (imaging solution) through an intravenous line

    A special type of scan called FAPI PET/CT will be performed to examine lung tissue in detail

  3. Step 3

    Monitoring period

    Your condition will be monitored for 12 months

    Regular check-ups will track any changes in lung function

    If you are already taking medications for your condition, you may continue them if the dose has been stable for at least 3 months

  4. Step 4

    Additional procedures for specific cases

    If your lung condition shows signs of worsening, a bronchial wash (collecting fluid samples from the lungs) may be performed

    This procedure helps examine the environment inside the lungs before any changes to treatment

  5. Step 5

    Final evaluation

    After 12 months, your lung function will be assessed to determine if any progression has occurred

    The results from your initial scan will be compared with your disease progression over the year

Who can join the trial?

13 criteria

  • Age between 18 and 75 years (both men and women can participate)
  • Must sign an informed consent form
  • Must have one of these diagnosed conditions:
    • Systemic Sclerosis (SSc)
    • Rheumatoid Arthritis (RA)
    • Sjögren's Syndrome (SS)
    • Inflammatory Muscle Disease (IIM)
    • Undifferentiated Connective Tissue Disease (UCTD)
    • Must have specific blood test results showing certain antibodies depending on their condition
    • Must have evidence of lung tissue changes (called interstitial lung disease) affecting at least 10% of the lungs, shown on a high-resolution CT scan within the past 6 weeks
    • Must either:
      • Never have taken medications that suppress the immune system, or
      • Have been on a stable dose of these medications for at least 3 months before the PET/CT scan
      • If previously treated with rituximab (a specific medication), the last dose must have been more than 24 weeks ago
      • Patients who need a lung washing procedure (bronchoalveolar lavage) must show signs that their lung condition is getting worse

Who cannot join the trial?

12 criteria

  • Patients under 18 years old cannot participate in the study
  • Patients with claustrophobia (fear of confined spaces) as they will need to undergo imaging tests in enclosed machines
  • Pregnant or breastfeeding women
  • Patients who have had major surgery within the last 3 months
  • Patients with metal implants or devices that would interfere with imaging tests
  • Patients who cannot lie flat for at least 30 minutes during scanning procedures
  • Patients with severe kidney disease (as contrast agents may be needed for imaging)
  • Patients with known allergies to contrast materials used in imaging
  • Patients who are unable to provide informed consent
  • Patients currently participating in other clinical trials
  • Patients with uncontrolled comorbidities (other medical conditions that are not well managed)
  • Patients who have received experimental treatments within the past 30 days
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Investigated drugs

Based on the provided trial information, there are no specific medications listed in the source data. The trial appears to be an observational study focusing on imaging techniques, specifically FAPI PET/CT scans, to monitor lung fibrosis in patients with connective tissue disease-related interstitial lung disease (CTD-ILD). This is a diagnostic study that does not involve testing any medications or therapeutic interventions. The study uses imaging technology to observe disease progression rather than testing any drugs or treatments.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The trial appears to be an observational study focusing on imaging techniques (FAPI PET/CT) to monitor lung disease progression in patients with connective tissue diseases, without any specific drug interventions mentioned. If you would like medication descriptions, please provide trial data that includes specific medications or therapeutic substances.

Investigated diseases

  • Connective Tissue Disease-associated Interstitial Lung Disease (CTD-ILD)

    A condition where the lungs become inflamed and scarred as a complication of various connective tissue diseases. The disease causes gradual thickening and stiffening of lung tissue, which affects normal breathing. It typically starts with inflammation in the lungs that can lead to scarring over time. The scarring can occur in different patterns throughout the lungs, making it harder for oxygen to pass from the air sacs into the bloodstream. Symptoms usually develop gradually and may include shortness of breath, especially during physical activity, and a dry cough.

  • Interstitial Lung Disease (ILD)

    A group of disorders that cause inflammation and scarring of the lung tissue, particularly in the area between air sacs. The condition affects the interstitium, which is the tissue and space around the air sacs of the lungs. As the lung tissue becomes stiff and thick, it becomes more difficult to breathe. The condition can develop gradually, causing progressive changes in the lung structure. Common symptoms include dry cough and shortness of breath during everyday activities.

  • Connective Tissue Disease (CTD)

    A group of disorders that affect the body's connective tissues, including skin, muscles, tendons, and ligaments. These diseases occur when the body's immune system mistakenly attacks its own tissues. The condition can affect multiple organs and body systems simultaneously. The symptoms vary depending on which tissues are affected but often include joint pain, muscle weakness, and skin changes.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516304-42-00Protocol codeCOOPERATION 2.0Estimated enrolment35 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

sourced from the EU Clinical Trials Register and site verification

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