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RecruitingNAINTERVENTIONAL

Study on Sex-specific, Individualized Dose Calculation of Contrast Agent in CT Examinations

This research is investigating how we use contrast dye in CT scans. Currently, the amount of dye is often based on body weight. However, previous studies suggest women often show clearer CT images with the same amount of dye compared to men, likely due to differences in blood volume. This study aims to test if giving a personalised amount of dye, calculated based on an individual's blood volume, can make CT scan results more consistent for both sexes. By doing this, researchers hope to get equally clear images for everyone, potentially reducing any differences currently seen between men and women in their scan results.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital Augsburg
Enrolment target
400
Start
01 Apr 2025
Estimated completion
01 Mar 2027

What is this study about?

Imagine you're having a special type of X-ray called a CT scan, and to see certain parts of your body more clearly, doctors might give you a special liquid called a 'contrast dye' through a vein. This dye helps things like blood vessels and organs show up better on the scan.

Currently, the amount of contrast dye given is often based on how much you weigh. However, studies have hinted that women might respond differently to the same dose of dye compared to men, possibly because men and women often have different amounts of blood in their bodies, even if they weigh the same. This means that a standard dose might not work exactly the same for everyone. For example, a woman might end up with a slightly higher concentration of the dye in her system than a man of the same size, leading to slightly different scan results.

This new study wants to explore this further. Researchers will compare two groups of people having a CT scan. One group will get the usual dose of contrast dye based on their weight. The other group will receive a personalised dose, carefully calculated based on their estimated blood volume. The main goal is to see if this personalised approach can help make CT scan images equally clear and consistent for both men and women, ensuring everyone gets the most accurate and helpful scan possible. They hope this will lead to a 'one-size-fits-one' approach rather than 'one-size-fits-all' for contrast delivery.

Key takeaways

  • Study looks at how contrast dye is given in CT scans.
  • Aims to make CT images clearer and more consistent for everyone.
  • Compares current dosing methods with a new, personalised approach.
  • New approach considers individual blood volume, not just weight.
  • Could lead to more accurate CT results for both men and women.

Who may be eligible?

This study is looking for adults aged 18 or older who need a CT scan of their chest and tummy where contrast dye will be used. You must be able to understand the study information and agree to take part in writing.

There are some reasons why you wouldn't be able to join. For example, if you're not well enough to have the scan, if you're pregnant, or if you've had certain operations like liver or spleen removal. You also can't take part if you have a known allergy to iodine contrast dye, severe kidney problems, or an overactive thyroid gland.

To be eligible, your height needs to be between 140 cm (about 4 feet 7 inches) and 220 cm (about 7 feet 2 inches), and your weight needs to be between 50 kg (about 7 stone 12 pounds) and 120 kg (about 18 stone 12 pounds). Oh, and your height and weight must be measured during your current hospital visit.

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.

  1. Are you 18 years old or over?
  2. Do you need a CT scan of your chest and tummy with contrast dye?
  3. Do you understand and agree to take part?
  4. Are you able to have your height and weight measured?
  5. Are you free from severe kidney problems or a confirmed allergy to iodine dye?
Answer every question to see your result.

What does participation involve?

If you join this study, you will have a CT scan of your chest and tummy, just as you would normally for your medical care. The only difference is the way the amount of contrast dye is decided. You’ll either receive the standard amount based on your weight or a specially calculated amount based on your estimated blood volume. There are no additional visits or assessments beyond what your doctor has already recommended for your CT scan. The total duration of your involvement would be the time it takes to prepare for and complete your CT scan.

Potential risks and benefits

Taking part in this study may or may not directly benefit you, but it could help doctors understand how to give contrast dye more effectively in the future. The risks involved are generally the same as having a standard CT scan with contrast dye, which your doctor would have already discussed with you. You might experience common side effects of the dye, like a warm feeling or a metallic taste. You are free to stop participating in the study at any time without affecting your medical care.

Locations (1)

  • University Hosptial Augsburg
    Verified postcode
    Augsburg, Germany· Recruiting

Common questions

What is a CT scan?

A CT scan is a special X-ray that takes detailed pictures inside your body, helping doctors see organs and blood vessels more clearly.

Why is contrast dye used?

Contrast dye helps certain parts of your body show up better on the CT scan, making it easier for doctors to spot problems.

Will I get a different type of CT scan?

No, you will have the same type of CT scan your doctor has already recommended. The only change is how the amount of contrast dye is calculated.

Is the contrast dye safe?

The contrast dye used is a standard medication. Your medical team will discuss any known risks or allergies with you before your scan.

Can I leave the study at any time?

Yes, you can choose to stop participating in the study at any point without it affecting your medical treatment.

How to find out more

Claudia Wollny, Dr.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study on Sex-specific, Individualized Dose Calculation of Co…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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