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Evaluation of Lung Function Using Xenon Gas with CT Imaging in Lung and Breast Cancer Patients Receiving Radiotherapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study looks at lung cancer and breast cancer in people who are receiving radiotherapy, which is a treatment that uses high-energy rays to destroy cancer cells. Radiotherapy can sometimes cause changes or damage to the lung tissue, leading to conditions such as radiation pneumonitis, which is inflammation of the lungs, or radiation fibrosis, which is scarring of the lung tissue. The study will use a special gas mixture called Messer mixture 30 Vol% Xe in 70 Vol% O2, which contains xenon and oxygen. This gas mixture will be breathed in by participants and acts as a contrast agent, meaning it helps create clearer images during scanning. The scanning method used is called Dual-Energy CT-imaging, which is a type of computed tomography scan that can show both the structure of the lungs and how well they are working.

The purpose of this study is to collect detailed information about lung structure and function before and after radiotherapy treatment. By comparing images taken before treatment starts with images taken after treatment is completed, researchers want to see what changes happen in the lungs as a result of the radiotherapy. These changes will be looked at by examining ventilation maps, which are special images that show how air moves through different parts of the lungs. The study aims to identify areas where the lung function may have improved or worsened due to the radiation treatment.

During the study, participants will undergo scanning sessions where they will breathe in the xenon and oxygen gas mixture while lying in the CT scanner. The scans will capture images of the lungs while the gas is present, allowing doctors to see which areas of the lungs are receiving good airflow and which areas may not be working as well. Participants will need to hold their breath for short periods of about three seconds during the scanning. The study will involve scans done before the radiotherapy begins and again after the radiotherapy treatment has finished, so that doctors can measure and compare any changes that have occurred in lung function and tissue structure.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial imaging scan before treatment
Before starting radiation therapy, a special imaging scan will be performed to assess lung function.
This scan uses a technique called Dual-Energy CT imaging, which is an advanced type of computed tomography scan that takes detailed pictures of the lungs.
During the scan, a gas mixture will be inhaled to help visualize how air moves through the lungs. This gas mixture contains 30% xenon and 70% oxygen.
The gas is administered through inhalation, meaning it will be breathed in during the scan.
The scan requires holding breath for 3 seconds to capture clear images.
This initial scan creates a baseline map of lung ventilation, showing how air flows through different areas of the lungs before any treatment begins.
Step 2
Radiation therapy treatment period
After the initial imaging scan, radiation therapy treatment will be administered as planned by the treating physician.
The radiation therapy is the standard treatment for lung or breast cancer and is not modified by participation in this imaging study.
During this period, no additional imaging scans with the xenon gas mixture are performed.
Step 3
Follow-up imaging scan after treatment
After completing radiation therapy, a second imaging scan will be performed using the same method as the initial scan.
The same gas mixture of 30% xenon and 70% oxygen will be inhaled during this scan.
The scan again requires holding breath for 3 seconds.
This follow-up scan creates a second ventilation map of the lungs, showing how air flows through the lungs after radiation therapy.
The purpose of this second scan is to compare lung function before and after treatment, allowing assessment of any changes in the lung tissue caused by radiation therapy.
The comparison between the two scans will show any areas where ventilation patterns have changed, which may appear as different colored areas on the lung maps.

Who can join the trial?

7 criteria

You must have lung cancer or breast cancer with a TNM classification of I-IIIa, which is a system doctors use to describe the size of the tumor and whether the cancer has spread to nearby areas or lymph nodes
You must be between 50 and 80 years old
You must not have received any prior cancer treatment, meaning you have not had chemotherapy, radiation therapy, or surgery for cancer before
You must be able to hold your breath for 3 seconds
You must be in stable condition, meaning your health is not rapidly changing or worsening, and you are not currently staying in an ICU, which is an intensive care unit for very seriously ill patients
You must not have COPD GOLD IV, which is the most severe stage of chronic obstructive pulmonary disease, a serious lung condition that makes breathing very difficult
You must sign an informed consent form, which is a document showing you understand the study and agree to participate

Who cannot join the trial?

5 criteria

The study does not list specific exclusion criteria, which are conditions or situations that would prevent someone from participating in the clinical trial
You should discuss with the research team whether you are suitable for this study based on your individual health situation
General safety considerations for this type of imaging study may apply, such as allergies to contrast agents (special substances used to make images clearer) or inability to lie still during scanning
Women who are pregnant (expecting a baby) or breastfeeding (nursing a baby) may not be able to participate due to radiation exposure
People with severe breathing problems may not be able to safely breathe the gas mixture containing xenon (a special gas used for imaging) and oxygen

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Vrije Universiteit Brussel
Jette, Belgium

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Investigated drugs

Xenon gas mixture is a breathable gas used as a contrast agent during special CT scans to help doctors see how well your lungs are working. In this study, you will breathe in a mixture that contains 30% xenon gas combined with 70% oxygen. This gas mixture is safe to breathe and helps create detailed images that show which parts of your lungs are ventilating properly. The images help doctors understand how radiation therapy affects your lung tissue.

XENON (133XE)

What is already known about the treatment

Xenon Gas 30% in Oxygen 70% – This is a breathing gas mixture used as a contrast agent during special CT scans to evaluate how well the lungs are working. It is currently being studied in clinical trials to help doctors see detailed images of lung ventilation in patients receiving radiation therapy for lung and breast cancer. The xenon gas temporarily enters the lung tissue when inhaled, allowing advanced imaging technology to create maps showing which parts of the lungs are functioning properly and which areas may be damaged by radiation treatment. This diagnostic mixture helps medical teams assess and monitor radiation-induced lung injuries such as inflammation and scarring of lung tissue.

Investigated diseases

Radiation Pneumonitis
Radiation pneumonitis is an inflammation of the lungs that occurs as a side effect of radiation therapy to the chest area. This condition typically develops within weeks to months after receiving radiation treatment for cancers such as lung or breast cancer. The lung tissue becomes inflamed and swollen in the areas that were exposed to radiation. Patients may experience symptoms such as shortness of breath, cough, and chest discomfort. The condition can affect the normal functioning of the lungs and reduce their ability to exchange oxygen efficiently. In some cases, the inflammation may resolve on its own, while in others it can progress to more persistent changes in the lung tissue.
Radiation-Induced Pulmonary Fibrosis
Radiation-induced pulmonary fibrosis is a condition where lung tissue becomes scarred and stiff following radiation therapy to the chest. This typically develops months to years after the completion of radiation treatment. The radiation causes permanent damage to the lung tissue, leading to the formation of fibrous scar tissue that replaces normal, healthy lung tissue. As the fibrosis progresses, the lungs lose their elasticity and ability to expand properly during breathing. This results in reduced lung capacity and difficulty breathing, particularly during physical activity. The scarring process is generally irreversible and represents a chronic change in the lung structure.
Lung Cancer
Lung cancer is a disease in which abnormal cells grow uncontrollably in one or both lungs, forming tumors that interfere with normal lung function. These cancerous cells typically start in the lining of the airways or in the air sacs of the lungs. As the cancer grows, it can block airways, cause fluid buildup, and prevent the lungs from working properly. The disease may remain confined to the lungs initially but has the potential to spread to other parts of the body through the bloodstream or lymphatic system. Common symptoms include persistent cough, chest pain, shortness of breath, and coughing up blood. Lung cancer can develop over many years, often without noticeable symptoms in its early stages.
Breast Cancer
Breast cancer is a disease where cells in the breast tissue begin to grow abnormally and form a tumor. The cancer typically starts in the milk ducts or the glands that produce milk, but can also begin in other breast tissues. As the abnormal cells multiply, they form a lump or mass that can be felt during examination or seen on imaging tests. The cancer cells can invade nearby tissues and may spread to lymph nodes under the arm or near the collarbone. If left unchecked, the cancer cells can travel through the bloodstream or lymphatic system to other parts of the body. The growth rate and behavior of breast cancer varies widely depending on the specific type and characteristics of the cancer cells.