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A study to compare using a half dose of iomeprol versus a standard dose of iomeprol for imaging lung tumors with spectral CT scans.

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What is this trial about?

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

This study focuses on patients with thoracic neoplasms, which are tumors or growths located in the chest area. To monitor these growths, medical imaging is often required. This research aims to compare the effectiveness of using a reduced amount of iodinated contrast medium, a substance injected into the body to make internal structures clearer on scans, against the standard amount used during a spectral CT, a specialized type of computed tomography scan that provides highly detailed images of the body.

The specific substance being tested is iomeprol, which is administered through an intravenous injection, meaning it is delivered directly into a vein. During the trial, participants will undergo imaging using both the standard dose and half the dose of the contrast. The study will evaluate how well the images show blood vessels and organs to ensure that using a smaller amount of the substance still provides clear and useful information for monitoring the disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Participation in the study
The study involves a crossover process, which means two different methods will be used at different times to compare their effectiveness.
The first method involves receiving a standard dose of an iodinated contrast medium, which is a liquid substance injected into a vein to help make images from a CT scan (a type of medical imaging) clearer.
Step 2
First imaging procedure
An intravenous injection, which is an injection directly into a vein, of the contrast medium is performed.
This procedure is used to monitor thoracic neoplasms, which are growths or tumors located in the chest area.
Step 3
Second imaging procedure
After a period of time, a second CT scan is performed using a different protocol.
In this stage, half the dose of the iodinated contrast medium (the liquid substance containing iomeprol) is administered via intravenous injection.
Step 4
Evaluation of results
The results of the scans are analyzed to compare the image quality and the clarity of the blood vessels and liver.
The evaluation focuses on how well the blood vessels (such as the pulmonary arteries and aorta) and the liver appear on the images when using the different amounts of the contrast medium.

Who can join the trial?

6 criteria

You must be older than 18 years of age.
You must have a thoracic neoplasm, which is a medical term for a tumor or abnormal growth located in the chest area.
The tumor must be located in the pulmonary area (the lungs) or the pleura (the thin lining that surrounds the lungs).
You must be scheduled for a contrast-enhanced CT scan, which is a special type of X-ray imaging that uses a colored liquid called contrast to make body parts and blood vessels show up more clearly on the screen.
The scan must cover the thoracoabdominopelvic area, meaning it will take pictures of your chest, abdomen (belly), and pelvis.
The purpose of your scan must be staging, which is the process doctors use to find out how much the cancer has grown or spread in the body.

Who cannot join the trial?

7 criteria

Having a known allergy or an extreme sensitivity to iodinated contrast media (the special liquid used to make images clearer during a scan) or any of the ingredients used to make it.
Having renal insufficiency, which means the kidneys are not working well enough, specifically when the estimated glomerular filtration rate (eGFR)—a measurement used to check how well the kidneys filter waste from the blood—is less than 30 mL/min.
Refusing to take part in the study or being unable to provide informed consent, which is the formal agreement to participate after understanding all the details.
Problems that prevent the full use of the contrast liquid, such as trouble with venous access (getting a needle into a vein), problems with the injection machine, or issues with central venous access (a specialized tube placed in a large vein).
Having a body weight that is less than 50 kg or more than 90 kg.
Technical problems, such as the spectral CT scanner (a specialized type of X-ray machine used for detailed imaging) being broken or unavailable.
Being pregnant or having a possibility of being pregnant.

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Investigated drugs

Iomeprol is a contrast medium used during imaging tests like CT scans. It is injected into a vein to help make organs, blood vessels, and tumors show up more clearly on the images, allowing doctors to see more detail.

Iomeprol

What is already known about the treatment

Iomeprol - This medication is an injectable liquid that is administered directly into a vein to help doctors see clearly during imaging tests like CT scans. It is a widely used diagnostic tool in medical practice used to highlight blood vessels and organs so that abnormalities, such as tumors, can be easily identified. At a molecular level, it contains iodine, which absorbs X-rays more effectively than body tissues, creating a bright signal on the scan. This substance is classified as an iodinated contrast medium.

Investigated diseases

Thoracic neoplasm - This condition involves the abnormal and uncontrolled growth of cells within the chest area. These growths can form masses in organs such as the lungs, esophagus, or the structures surrounding them. As the condition progresses, the abnormal cells may multiply and expand within the chest cavity. The growth can affect the function of the nearby tissues and organs. Over time, the size and location of the mass may change.