Not recruitingRare disease

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

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 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.

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 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

5 criteria

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 trial?

10 criteria

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.

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Verified sites

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Verified
Aarhus University Hospital
Aarhus, Denmark
Responsive
Region Midtjylland
Aarhus, Denmark

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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.

What is already known about the treatment

Hyperpolarized 129-Xenon MRI – This is a non-invasive imaging technique used to study lung diseases, specifically progressive fibrosing interstitial lung diseases. It is currently being explored in clinical trials to assess its effectiveness in identifying and monitoring early signs of lung fibrosis and related heart issues. The main therapeutic indication is to provide detailed images of lung function, which can help in understanding disease progression and response to treatment. At the molecular level, hyperpolarized xenon gas is inhaled, and its magnetic properties are used to create high-resolution images of the lungs. This technique falls under the category of diagnostic imaging rather than a traditional pharmacological classification.

Investigated diseases

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.