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

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What is this study about?

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.

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.

2 consent and randomization

The patient provides consent to participate in the study. Following consent, the patient is randomized to a study group.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name City Country Status
Centre Hospitalier Regional Et Universitaire De Brest Brest France

Other Sites

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

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
22.06.2023

Trial locations

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.

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.

Trial ID:
2024-518293-13-01
NCT ID:
NCT05775562
Trial Phase:
Human Pharmacology (Phase I) – Other

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