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Study on PET/CT Imaging with [18F]-AlF-FAPI-74 for Identifying Fibrosis and Inflammation in Patients with Progressive Pulmonary Fibrosis

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What is this trial about?

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

This clinical trial is focused on studying a lung condition known as Progressive Pulmonary Fibrosis (PPF). This disease involves the thickening and scarring of lung tissue, which can make breathing difficult. The study will use a special imaging technique called PET/CT to help distinguish between two types of lung tissue changes: active fibrosis, which is the formation of scar tissue, and inflammation, which is the body's response to injury or infection.

The treatment being studied involves a substance called [18F]-AlF-FAPI-74, which is a solution for injection. This substance is used in the imaging process to help identify the different types of tissue changes in the lungs. The purpose of the study is to see if this imaging method can effectively tell the difference between active fibrosis and inflammation in patients with PPF.

Participants in the study will receive an injection of [18F]-AlF-FAPI-74 and then undergo a PET/CT scan. This scan will help researchers observe the activity in the lungs and determine the presence of fibrosis or inflammation. Some participants may receive a placebo instead of the active substance. The study aims to improve understanding of PPF and potentially lead to better treatment options in the future.

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
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as being 18 years or older, having a new diagnosis of progressive pulmonary fibrosis (PPF), and having at least 20% of lung tissue affected by fibrosis or inflammation.
The treatment plan includes either immunosuppressive drugs or antifibrotic drugs as indicated by a medical team.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for the study. This includes a PET/CT scan using [18F]-AlF-FAPI-74, a solution injected intravenously to help visualize the lung condition.
The scan aims to differentiate between active fibrosis and inflammation in the lungs.
Step 3
Imaging procedure
The PET/CT imaging procedure involves the administration of the [18F]-AlF-FAPI-74 solution. This is a radioactive tracer that helps in identifying areas of fibrosis and inflammation.
The imaging helps in measuring the concentration of FAPI activity, which is crucial for understanding the lung condition.
Step 4
Data analysis
Data from the imaging is analyzed to determine the activity thresholds for positive FAPI-PET/CT results, confirming active fibrosis.
The analysis also includes correlating baseline FAPI activity with the extent of lung disease and serum biomarkers for inflammation.
Step 5
Follow-up
Regular follow-up appointments are scheduled to monitor the condition and response to treatment.
These follow-ups may include additional imaging and assessments to track changes in lung condition over time.

Who can join the trial?

4 criteria

Must be **18 years of age** or older.
Must have a **new diagnosis** of Progressive Pulmonary Fibrosis (PPF).
At least **20% of the lung tissue** must be affected by abnormal changes, which could be **fibrosis** (thickening and scarring of tissue), **inflammation** (swelling and irritation), or both.
Must have a recommendation from a **multidisciplinary team (MDT)** for treatment with either **immunosuppressive drugs** (medications that reduce the activity of the immune system) or **antifibrotic drugs** (medications that slow down the scarring of tissue).

Who cannot join the trial?

10 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medication are excluded.
Patients with other serious health conditions that could interfere with the study are not eligible.
Participants who are currently involved in another clinical trial are not allowed to join.
Individuals who have had a recent major surgery may not participate.
Patients with uncontrolled high blood pressure are excluded.
Individuals with severe liver or kidney disease cannot take part in the study.
Patients who are unable to follow the study procedures or instructions are not eligible.
Individuals with a history of drug or alcohol abuse may be excluded.
Patients who have received certain treatments or medications recently may not be eligible.

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St. Antonius Ziekenhuis
Nieuwegein, The Netherlands

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Investigated drugs

FAPI is a special imaging agent used in PET/CT scans. It helps doctors see the difference between active fibrosis and inflammation in the lungs of patients with progressive pulmonary fibrosis. This imaging agent is important for understanding the type of lung changes a patient has, which can guide treatment decisions.

[Al[18F]F]Fapi-74

What is already known about the treatment

FAPI – FAPI is administered through an injection and is used in PET/CT imaging to help distinguish between active fibrotic and inflammatory conditions in patients with progressive pulmonary fibrosis. Currently, it is being studied in clinical trials to assess its effectiveness as a biomarker for identifying different phenotypes of pulmonary fibrosis. The main therapeutic indication for FAPI is to aid in the diagnosis and management of progressive pulmonary fibrosis by providing detailed imaging of fibrotic and inflammatory activity. At the molecular level, FAPI targets fibroblast activation protein, which is often overexpressed in fibrotic tissues, allowing for precise imaging. It is classified as a diagnostic radiopharmaceutical agent.

Investigated diseases

Progressive Pulmonary Fibrosis – Progressive Pulmonary Fibrosis is a chronic lung disease characterized by the gradual scarring of lung tissue, which leads to a decline in lung function over time. The disease progresses as the fibrous tissue replaces normal lung tissue, making it increasingly difficult for the lungs to expand and contract. This results in symptoms such as persistent cough, shortness of breath, and fatigue. As the fibrosis worsens, patients may experience a decrease in oxygen levels in the blood, leading to further complications. The exact cause of the fibrosis can vary, and it may be associated with other conditions or environmental factors. The progression of the disease can vary significantly among individuals, with some experiencing rapid deterioration while others have a slower progression.