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Study on Pulmonary Embolism: Comparing Iomeprol Dosages in CT Scans for Patients with Suspected Pulmonary Embolism

Registered 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 the condition known as pulmonary embolism, which occurs when a blood clot blocks a blood vessel in the lungs. The study will use a special imaging technique called pulmonary CT angiography to help diagnose this condition. This technique involves using a type of X-ray called computed tomography (CT) to take detailed pictures of the blood vessels in the lungs. To improve the quality of these images, a substance called iodinated contrast is used. In this study, the contrast used is called Iomeron 400 mgI/ml solution for injection, which contains the active ingredient iomeprol.

The purpose of the study is to compare the quality and accuracy of the images produced by using three different amounts of the iodinated contrast: 20 mL, 30 mL, and 40 mL. Participants will be randomly assigned to receive one of these three amounts during their CT scan. The study aims to determine which amount provides the best images for diagnosing pulmonary embolism. The trial will measure how well the contrast highlights the blood vessels in the lungs and how accurately it helps detect blood clots.

Participants in the study will undergo a pulmonary CT angiography scan, where the contrast is injected into a vein, and images are taken to assess the blood flow in the lungs. The study will evaluate the images to see how well the different amounts of contrast work in identifying pulmonary embolism. This research will help improve the diagnosis of this condition by finding the most effective way to use the contrast during the scan.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the clinical trial, you will be enrolled as a participant. This involves confirming your eligibility based on the criteria that you have been referred for a pulmonary CT angiography to check for pulmonary embolism.
Step 2
Randomization
You will be randomly assigned to one of three groups. Each group receives a different amount of iodinated contrast during the CT scan: 20 mL, 30 mL, or 40 mL. The contrast helps to improve the quality of the images taken during the scan.
Step 3
Preparation for CT scan
Before the CT scan, you will be prepared for the procedure. This includes receiving the iodinated contrast solution, which is a solution for injection administered through an intravenous bolus. The contrast may be diluted with saline, depending on the group you are in.
Step 4
CT scan procedure
During the CT scan, images of your lungs will be taken to assess the presence of any blockages in the pulmonary arteries. The scan will also evaluate the quality of lung perfusion, which is how well blood flows through your lungs.
Step 5
Post-scan monitoring
After the CT scan, you will be monitored for a short period to ensure there are no immediate side effects from the contrast injection. This is a standard procedure to ensure your safety.
Step 6
Follow-up
You may be asked to return for follow-up visits to discuss the results of your CT scan and any findings related to the study. These visits are important for understanding the effectiveness of the contrast protocols used in the trial.

Who can join the trial?

4 criteria

Patients who are referred for a pulmonary CT angiography. This is a special type of scan that looks at the blood vessels in the lungs.
Patients who are being checked for pulmonary thromboembolism. This is a condition where a blood clot blocks blood flow in the lungs.
Patients of any gender can participate.
Patients who are not considered part of a vulnerable population.

Who cannot join the trial?

3 criteria

Patients who have a history of **pulmonary embolism** cannot participate. A pulmonary embolism is a blockage in one of the pulmonary arteries in your lungs.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population cannot participate. This means people who might be at higher risk of harm or exploitation.

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Investigated drugs

Iodinated Contrast is a special liquid used in medical imaging to help doctors see the inside of your body more clearly. In this trial, it is used during a type of scan called a pulmonary CT angiography, which looks at the blood vessels in your lungs. The contrast helps highlight these vessels, making it easier for doctors to check for any blockages or other issues.

Iomeprol

What is already known about the treatment

Iodinated Contrast – This medication is administered intravenously as part of a CT angiography procedure to help visualize blood vessels in the lungs, particularly for diagnosing pulmonary embolism. Currently, it is widely used in medical imaging and is well-documented in medical literature for its effectiveness in enhancing the clarity of CT scans. The main therapeutic indication is to improve the diagnostic quality and accuracy of pulmonary CT angiography. At the molecular level, iodinated contrast works by absorbing X-rays, which increases the contrast of the images, making it easier to see blood vessels and any blockages. It is classified as a radiographic contrast agent.

Investigated diseases

Pulmonary Embolism – Pulmonary embolism is a condition where one or more arteries in the lungs become blocked by a blood clot. This blockage can restrict blood flow to the lungs, leading to reduced oxygen levels in the blood. The condition often begins with a clot forming in the deep veins of the legs, known as deep vein thrombosis, which then travels to the lungs. As the clot lodges in the lung arteries, it can cause sudden shortness of breath, chest pain, and coughing. The progression of the disease can lead to increased pressure on the right side of the heart. Over time, this can result in damage to the lung tissue due to lack of blood flow.