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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	04.11.2024

Trial locations

Investigated drugs:

[18F]Fapi-74

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.

Investigated diseases:

Interstitial lung disease

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 ID:

2024-516304-42-00

Protocol code:

COOPERATION 2.0

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

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