Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Randomized clinical trial comparing the diagnostic quality and diagnostic accuracy of pulmonary CT angiography performed with spectral CT among three iodinated contrast administration protocols, with 20, 30 and 40 mL

This research is a study comparing three different ways to perform a CT pulmonary angiogram scan, which is a type of X-ray to check for blood clots in the lungs, called pulmonary embolism. We are specifically looking at how much of a special dye (called 'contrast') is needed to get the clearest and most helpful pictures. The study will compare using 20ml, 30ml, or 40ml of this dye. The main goal is to find out which amount of dye gives the best image quality for detecting blood clots and assessing how well blood flows in the lungs, ultimately aiming to improve patient safety and the accuracy of diagnosis. This is a Phase IV study, meaning the treatment (the scan method) is already in use, and we are fine-tuning how it's done.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Hospital General Universitario Dr. Balmis

Enrolment target

150

Start

16 Oct 2024

pulmonary embolism

What is this study about?

This study is all about improving a very important type of scan called a CT pulmonary angiogram. This scan is used to look for blood clots in the lungs, a condition known as pulmonary embolism, which can be serious. To make these clots visible on the scan, a special dye, called 'contrast material,' is injected into your bloodstream.

What we want to find out is which amount of this dye works best. We are comparing three different amounts: 20ml, 30ml, and 40ml. Our aim is to see if we can use less dye while still getting excellent quality pictures that clearly show any blood clots and how well blood is flowing in your lungs. This is important because using less dye can be safer for patients, especially for those with kidney problems.

By finding the best and most efficient way to do this scan, we hope to make the diagnosis of pulmonary embolism even more accurate and patient-friendly. This study is considered a 'Phase IV' study, which means the general method of the scan is already used in hospitals, but we are doing research to make it even better and safer for everyone.

Key takeaways

A study looking at ways to improve CT scans for lung clots.
Compares using different amounts of dye (20ml, 30ml, or 40ml).
Aims for clearer scans with potentially less dye, enhancing safety.
You would be an adult undergoing a CT pulmonary angiogram.
Helps improve diagnosis of pulmonary embolism for future patients.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. Both men and women can take part.

The main requirement is that you are having a CT pulmonary angiogram because your doctor thinks you might have a blood clot in your lungs. The study is for people who would be getting this scan anyway as part of their medical care.

There might be other reasons why you couldn't join, which the study team would discuss with you. These could include certain health conditions or medications that might affect the scan or your safety in the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you a man or a woman?
Is your doctor sending you for a CT scan to check for blood clots in your lungs?
Are you able to have a standard CT scan with contrast dye?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your participation will be quite straightforward, as it focuses on a scan you would likely be having anyway. You will undergo a CT pulmonary angiogram scan as planned by your doctor. The main difference is that, as part of the study, you will receive one of three specific amounts of the contrast dye (20ml, 30ml, or 40ml) for the scan. There will be no extra visits specifically for the study beyond your scheduled medical appointments. The total duration of your participation would effectively be the time it takes to prepare for and complete the CT scan itself, and then possibly some follow-up by your medical team as part of your standard care, where the results of this particular scan method would be analysed.

Potential risks and benefits

A potential benefit of joining this study is that you would be contributing to improving how blood clots in the lungs are diagnosed, which could lead to better and safer care for many patients in the future. There's also a chance that the images from your scan might be of particularly high quality. Potential risks are generally similar to those of a standard CT pulmonary angiogram, such as a possible reaction to the contrast dye (like a warm flush, nausea, or rarely, an allergic reaction). There's also exposure to a small amount of radiation, as with any CT scan. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain

Common questions

What is a pulmonary embolism?

It's a serious condition where a blood clot gets stuck in an artery in your lungs, blocking blood flow.

What is contrast dye?

It's a special liquid injected into your arm that helps doctors see blood vessels and organs more clearly on X-ray scans.

Will I get less dye if I join the study?

You will receive either 20ml, 30ml, or 40ml of dye, as chosen randomly for the study, instead of the standard amount your doctor usually uses.

Is the CT scan safe?

CT scans use X-rays, so there's a small amount of radiation exposure, similar to other diagnostic X-rays. Your doctor will discuss the risks and benefits with you.

How long does the study last for me?

Your involvement in the study is mainly during your CT scan appointment. There are no extra study visits.