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Study on Lung Function After Pulmonary Embolism Using Galligas and 68Ga-MAA in Patients with Pulmonary Embolism

Verified siteRegistered drugNo placebo

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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 the effects of a treatment for pulmonary embolism, a condition where one or more arteries in the lungs become blocked by a blood clot. The study will use two treatments: Pulmocis, which is a suspension for injection containing human albumin as macroaggregates, and Pulmotec, an inhalation powder containing graphite. These treatments are used to help assess lung function after a pulmonary embolism.

The purpose of the study is to evaluate how these treatments affect lung function using a special imaging technique called PET/CT, which combines positron emission tomography and computed tomography to create detailed images of the lungs. Participants will receive either the treatment or a placebo and will undergo several imaging sessions to monitor changes in lung function over time. The study aims to understand how well the lungs are working after treatment and to identify any improvements in breathing and overall lung health.

Throughout the study, participants will have regular check-ups and imaging tests to track their progress. The study will last for a period of time, during which participants will be closely monitored by healthcare professionals. The goal is to gather information that could help improve treatment options for people with pulmonary embolism 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
Initial assessment
The trial begins with an initial assessment to confirm eligibility. This includes verifying that the patient is at least 18 years old and has been treated with anticoagulation for 3 to 8 months for a pulmonary embolism.
The patient must have a PembQol score of at least 10% and specific scores for dyspnea and impact on daily life. An abnormal conventional ventilation/perfusion (V/Q) scan is also required.
Step 2
Consent and randomization
The patient provides consent to participate in the study. Following consent, the patient is randomized to a study group.
Step 3
Medication administration
The patient receives two types of medications: Pulmocis and Pulmotec. Pulmocis is a suspension for injection containing human albumin as macroaggregates, and Pulmotec is an inhalation powder containing graphite.
These medications are used to prepare for the V/Q PET/CT imaging, which assesses lung function.
Step 4
Imaging and assessment
The patient undergoes V/Q PET/CT imaging to evaluate lung function. This imaging helps assess the pulmonary vascular obstruction index, which is expressed as a percentage of the whole lung volume.
Secondary assessments include regional lung functional volumes, global lung function parameters, and quality of life scores.
Step 5
Follow-up and conclusion
The trial continues with follow-up assessments to monitor changes in lung function and quality of life over time.
The estimated end date for the trial is December 22, 2025.

Who can join the trial?

6 criteria

Must be **18 years or older**.
Must have been treated with **blood-thinning medication** for at least 3 months and up to 8 months for a recent **pulmonary embolism** (a condition where a blood clot blocks blood flow in the lungs), diagnosed according to specific medical guidelines.
Must have a **PembQol score** of 10% or higher. This score measures the quality of life related to pulmonary embolism, including **breathing difficulties** and the **impact on daily life**.
Must be planned to be **randomly assigned** to different groups in the study.
Must have an **abnormal lung scan** at the first visit. This scan checks how well air and blood are flowing in the lungs.
Must agree to **participate in the EOLE study** by giving consent.

Who cannot join the trial?

3 criteria

Patients who have a history of **pulmonary embolism**. This is a condition where a blood clot blocks a blood vessel in the lungs.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.

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Verified sites

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Centre Hospitalier Regional Et Universitaire De Brest
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Brest, France

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Investigated drugs

Galligas
is a type of gas used in imaging tests to help doctors see how well air is moving through the lungs. In this trial, it is used in combination with a special type of scan called PET/CT to assess lung function after a pulmonary embolism.
68Ga-MAA
is a radioactive substance used in imaging tests to help doctors see how well blood is flowing through the lungs. It is used in this trial with PET/CT scans to evaluate lung perfusion, which is how well blood is reaching different parts of the lungs after a pulmonary embolism.

What is already known about the treatment

Galligas
Galligas is administered through inhalation and is used in combination with imaging techniques to assess lung function. It is currently being studied in clinical trials for its effectiveness in evaluating lung perfusion after pulmonary embolism. The main therapeutic indication is to provide detailed imaging of lung ventilation, helping doctors understand how well different parts of the lungs are functioning. At the molecular level, Galligas works by emitting positrons that are detected by PET/CT scans, allowing for precise imaging of air distribution in the lungs. It is classified as a diagnostic radiopharmaceutical agent.
68Ga-MAA
68Ga-MAA is administered via intravenous injection and is used in conjunction with imaging technologies to evaluate lung perfusion. It is under investigation in clinical trials for its role in assessing lung function following pulmonary embolism. The primary therapeutic indication is to offer detailed imaging of blood flow in the lungs, aiding in the diagnosis and management of pulmonary conditions. The mechanism of action involves the binding of 68Ga-MAA to blood components, which then emits positrons detectable by PET/CT scans, providing clear images of blood distribution in the lungs. It is classified as a diagnostic radiopharmaceutical agent.

Investigated diseases

Pulmonary Embolism – A pulmonary embolism occurs when a blood clot blocks one or more arteries in the lungs. This blockage can restrict blood flow, leading to reduced oxygen levels in the blood. Symptoms may include sudden shortness of breath, chest pain, and coughing, sometimes with blood. The condition can develop rapidly and may cause significant strain on the heart and lungs. Over time, it can lead to complications such as pulmonary hypertension if not addressed. The severity of symptoms can vary depending on the size and location of the clot.