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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

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

Where you can join this trial?

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Other Sites

Site Name City Country Status
St. Antonius Ziekenhuis Nieuwegein The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
01.01.2024

Trial locations

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.

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.

Trial ID:
2023-503686-26-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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