Study on the Use of Hyperpolarized Xenon (129Xe) and Gadobutrol for Imaging in Patients with Progressive Fibrosing Interstitial Lung Diseases

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What is this study about?

This clinical trial is focused on studying a group of lung diseases known as Progressive Fibrosing Interstitial Lung Diseases. These diseases cause scarring of the lung tissue, which can make it difficult to breathe. The study will use a special type of imaging called Hyperpolarized 129-Xenon MRI to look at the lungs. This imaging technique involves inhaling a gas called Xenon (129Xe), which helps to create clear pictures of the lungs. The purpose of the study is to see if this imaging can help identify early signs of lung scarring and monitor changes over time.

In addition to the Xenon (129Xe) gas, the study will also use a contrast agent called Gadovist, which is injected into the body to help highlight certain areas during imaging. The study aims to understand how these imaging techniques can be used to track the progression of lung disease and the effects on the heart. Researchers will also evaluate how patients respond to treatments that aim to slow down the scarring process.

Participants in the study will undergo imaging sessions where they will inhale the Xenon (129Xe) gas and receive the Gadovist injection. These sessions will help researchers gather information about lung function and heart health. The study will take place over a period of time, allowing researchers to monitor changes and gather valuable data on the effectiveness of these imaging techniques in managing lung diseases.

1 initial visit

Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on criteria such as age, diagnosis of fibrosing interstitial lung disease, and cognitive ability to participate.

Pre-menopausal women will undergo a pregnancy test to ensure eligibility.

2 baseline assessment

A baseline assessment is conducted to gather initial health data. This includes a magnetic resonance imaging (MRI) scan using hyperpolarized 129-xenon gas to assess lung function.

The MRI scan involves inhaling a solution of hyperpolarized 129-xenon gas. Different volumes of the gas, such as 800 ml, 500 ml, 650 ml, 1000 ml, or 400 ml, may be used depending on the specific requirements of the scan.

3 medication administration

During the trial, the medication gadobutrol is administered as a solution for injection. This is used to enhance the quality of the MRI images.

The dosage and frequency of gadobutrol administration are determined by the study protocol and are explained during the trial.

4 follow-up visits

Regular follow-up visits are scheduled to monitor health and assess the effects of the treatment. These visits include repeated MRI scans and other tests to evaluate lung function and any changes in symptoms.

The frequency and duration of these visits are specified in the study protocol and communicated during the trial.

5 end of trial

At the end of the trial, a final assessment is conducted to gather concluding data on health status and treatment effects.

Participants are informed about the results and any further steps if necessary.

Who Can Join the Study?

Patients must be diagnosed with IPF (Idiopathic Pulmonary Fibrosis) or fibrotic ILD (Interstitial Lung Disease) and meet the criteria for PPF (Progressive Pulmonary Fibrosis).
Patients must be prescribed antifibrotic treatment.
Patients must be between the ages of 18 and 90.
Patients must be able to understand and participate in the study.
Pre-menopausal women must have a negative pregnancy test conducted at the study site.

Who Cannot Join the Study?

Patients with any other serious health condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients who are unable to follow the study procedures or instructions.
Patients with a known allergy to any of the study medications or procedures.
Patients with a history of drug or alcohol abuse within the past year.
Patients with unstable or uncontrolled heart disease.
Patients with severe liver or kidney disease.
Patients with active cancer or undergoing cancer treatment.
Patients with any infection that requires treatment with antibiotics.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Region Midtjylland	Aarhus	Denmark
Ajhpqu Uinyowgliw Hcbcrsru	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

Hyperpolarized 129-Xenon MRI is a special type of imaging technique used in this clinical trial. It involves using a gas called xenon, which is hyperpolarized, meaning it is prepared in a way that makes it easier to see in MRI scans. This technique helps doctors get a clearer picture of the lungs and how they are functioning. In this trial, it is used to look for early signs of lung disease and to see how the disease affects the heart. This imaging method is non-invasive, which means it does not require surgery or entering the body, making it a safer option for patients.

Investigated diseases:

Interstitial lung disease

Progressive Fibrosing Interstitial Lung Diseases – This group of diseases is characterized by the gradual scarring of lung tissue, which leads to a decline in lung function over time. The scarring, or fibrosis, makes the lung tissue stiff, reducing its ability to expand and contract, which impairs breathing. As the disease progresses, patients may experience increasing shortness of breath, a persistent dry cough, and fatigue. The progression of fibrosis can vary among individuals, with some experiencing a rapid decline in lung function while others may have a slower progression. Over time, the reduced lung capacity can lead to decreased oxygen levels in the blood, affecting overall health and quality of life. The disease can also lead to complications such as pulmonary hypertension and heart strain due to the increased effort required to pump blood through the stiffened lungs.

Trial ID:

2022-502512-36-00

Protocol code:

Xe-F-ILD-001

NCT ID:

NCT05914506

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Use of Hyperpolarized Xenon (129Xe) and Gadobutrol for Imaging in Patients with Progressive Fibrosing Interstitial Lung Diseases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?