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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 Progressive Pulmonary Fibrosis (PPF), a lung disease where the tissue in the lungs becomes thick and stiff, making it difficult to breathe. The study will use a special imaging technique called PET/CT with a substance known as [18F]-AlF-FAPI-74. This substance is injected into the body and helps to highlight areas of the lungs that are affected by fibrosis or inflammation, which are two different types of tissue changes that can occur in PPF.

The purpose of the study is to see if this imaging method can help doctors tell the difference between areas of the lung that are mostly fibrotic (thickened tissue) and those that are mostly inflamed (swollen tissue). This could help in understanding the disease better and in deciding the best treatment approach for patients with PPF. Some patients in the study may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

Participants in the study will undergo the PET/CT imaging process, which involves lying still while a machine takes detailed pictures of the inside of the body. The study will track how the [18F]-AlF-FAPI-74 substance behaves in the body and how it highlights the different types of lung tissue. The study aims to gather information over a period of time to see how well this imaging technique works in identifying the different patterns of lung changes in PPF.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age (18 years or older), a new diagnosis of progressive pulmonary fibrosis (PPF), and that at least 20% of lung tissue is affected by fibrosis, inflammation, or both.
The assessment also checks for a recommendation from a medical team for treatment with either immunosuppressive or antifibrotic drugs.
Step 2
Preparation for imaging
Preparation for the imaging process involves scheduling a PET/CT scan. This scan uses a special imaging agent called [18F]-AlF-FAPI-74, which is a solution for injection administered intravenously.
The purpose of this imaging is to help distinguish between active fibrosis and inflammation in the lungs.
Step 3
Imaging procedure
During the imaging procedure, the [18F]-AlF-FAPI-74 solution is injected into a vein. This allows the PET/CT scan to capture detailed images of the lungs.
The scan measures the concentration of the imaging agent in areas of active fibrosis and inflammation, providing important information for the study.
Step 4
Data analysis
After the imaging procedure, the data collected from the PET/CT scan is analyzed. This analysis focuses on the activity concentration of the imaging agent in the lungs.
The results help determine the presence and extent of active fibrosis and inflammation, and correlate these findings with other clinical data.
Step 5
Follow-up
Follow-up appointments may be scheduled to monitor the patient's condition and gather additional data as needed.
The study aims to complete data collection and analysis by January 1, 2025.

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 abnormal, which means it has fibrosis (scarring), inflammation, or both.
Must have a recommendation from a **medical team** to start treatment with either drugs that suppress the immune system or drugs that reduce fibrosis.

Who cannot join the trial?

1 criterion

There are no specific exclusion criteria listed for this clinical trial.

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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. In this study, it helps doctors see the difference between active fibrosis and inflammation in the lungs of patients with progressive pulmonary fibrosis. This imaging agent binds to certain areas in the body, allowing doctors to get a clearer picture of what's happening inside the lungs.

[Al[18F]F]Fapi-74

What is already known about the treatment

FAPI – FAPI is administered through an injection and is used in PET imaging to help distinguish between active fibrotic and inflammatory phenotypes in patients with progressive pulmonary fibrosis. Currently, it is being studied in clinical trials to assess its effectiveness as a biomarker in this context. 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 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 difficult for the lungs to expand and contract properly. This scarring process can result in symptoms such as shortness of breath, a persistent dry cough, and fatigue. As the fibrosis worsens, it can lead to decreased oxygen levels in the blood and increased difficulty in breathing. The progression of the disease varies among individuals, with some experiencing a slow decline and others a more rapid deterioration. The exact cause of the fibrosis is often unknown, but it can be associated with environmental factors, certain medications, or underlying health conditions.