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Study on [68Ga]FAPI-46 to Detect Fibroblast Activity in Patients with Non-Resolving Acute Respiratory Distress Syndrome (ARDS) in the ICU

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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 condition known as Acute Respiratory Distress Syndrome (ARDS), specifically in cases where the condition does not improve over time, referred to as non-resolving ARDS. The study will use a special imaging technique called PET/CT to observe the activity of certain cells in the lungs that are involved in the formation of fibrous tissue, which can affect breathing.

The treatment being studied involves a solution for injection called [68Ga]FAPI-46. This is a chemical substance that helps to highlight the activity of fibrogenic cells in the lungs when viewed through the PET/CT scan. The purpose of the study is to understand how the activity of these cells relates to the patient's recovery, including their survival after 28 days, the number of days they can breathe without a ventilator, and the length of their stay in the intensive care unit (ICU).

During the study, patients with non-resolving ARDS who are on mechanical ventilation will receive the [68Ga]FAPI-46 injection. The PET/CT scan will then be used to visualize the activity of the fibrogenic cells in their lungs. The study aims to gather information on how this activity is connected to various health outcomes, such as the patient's respiratory condition and certain markers in their blood that indicate inflammation. The study will also evaluate the PET/CT procedure itself to ensure it is safe and effective for patients.

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, you will be required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the study.
You must meet certain criteria, such as being an adult over 19 years of age, being mechanically ventilated, and having a specific lung condition called non-resolving ARDS.
Step 2
Initial assessment
A healthcare professional will assess your condition to ensure it is safe for you to be transported for the study procedures.
For patients with COVID-19, a specific test result is required to proceed.
Step 3
Administration of medication
You will receive an injection of a solution called [68Ga]FAPI-46. This is administered through a vein, a process known as intravenous administration.
The purpose of this medication is to help visualize certain cell activities in your lungs using a special imaging technique.
Step 4
Imaging procedure
After receiving the injection, you will undergo a PET/CT scan. This is a type of imaging that helps doctors see how your lungs are functioning.
The scan will help measure the activity of specific cells in your lungs, which is important for understanding your condition.
Step 5
Monitoring and follow-up
Your health and response to the study procedures will be monitored closely. This includes checking how your lungs are functioning and any changes in your condition.
The study aims to relate the findings from the imaging to your overall health outcomes, such as your stay in the intensive care unit and your recovery over 28 days.

Who can join the trial?

8 criteria

Adult patients who are male or female and older than 19 years.
Patients who are on a mechanical ventilator (a machine that helps with breathing).
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Patients who meet the criteria for non-resolving ARDS (a severe lung condition) on the 5th day after diagnosis, with at least one of the following:
- P/F ratio (a measure of lung function) less than 200 mmHg.
- Positive End Expiratory Pressure (PEEP) of 12 cmH2O or more (a setting on the ventilator).
- Static lung compliance less than 50 ml/cmH2O (a measure of lung stiffness).
- Patients who are considered safe for transport by the attending clinician (doctor in charge).
- Patients or their legal representative must have signed an informed consent form (agreement to participate after understanding the study).
- For patients with COVID-19, a SARS-CoV-2 PCR CT (a type of test for the virus) greater than 30 is required.

Who cannot join the trial?

3 criteria

Patients with a condition called Non-resolving ARDS cannot participate. ARDS stands for Acute Respiratory Distress Syndrome, which is a severe lung condition.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to certain vulnerable groups may not be eligible to participate.

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Universitair Medisch Centrum Groningen
Groningen, The Netherlands

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Investigated drugs

[68Ga]-FAPI is a special type of imaging agent used in a PET/CT scan. It helps doctors see the activity of certain cells called fibroblasts in the lungs. This is important for patients with a condition called ARDS, where the lungs don't heal properly. By using this imaging agent, doctors can better understand how active these fibroblasts are, which might help predict how the patient's condition will progress and how long they might need to stay in the ICU.

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

What is already known about the treatment

[68Ga]-FAPI – This medication is administered through an injection and is used in a PET/CT scan to detect fibroblast activity in patients with non-resolving Acute Respiratory Distress Syndrome (ARDS) in the Intensive Care Unit (ICU). Currently, it is being studied in clinical trials to understand its effectiveness in predicting outcomes like mortality and ventilator-free days in these patients. The main therapeutic indication is to assess fibroblast activity in the lungs, which can help in understanding the severity and progression of ARDS. At the molecular level, [68Ga]-FAPI binds to fibroblast activation protein, which is often present in areas of tissue remodeling and inflammation, allowing for imaging of these processes. It is classified as a radiopharmaceutical used for diagnostic imaging.

Investigated diseases

Acute Respiratory Distress Syndrome (ARDS) – Acute Respiratory Distress Syndrome is a severe lung condition characterized by rapid onset of widespread inflammation in the lungs. It leads to fluid accumulation in the air sacs, which results in decreased oxygen reaching the bloodstream. The condition progresses with difficulty in breathing and low blood oxygen levels, often requiring mechanical ventilation support. In non-resolving cases, the inflammation and fluid buildup persist, leading to prolonged respiratory failure. Over time, this can cause scarring and fibrosis of lung tissue, further impairing lung function. The progression of ARDS can vary, with some patients experiencing gradual improvement while others may have persistent or worsening symptoms.