RecruitingOBSERVATIONAL

Elastographic Analysis of Urothelial Bladder Tumours

This research is investigating a new way to examine bladder tumours using a special type of ultrasound called elastography. Ultrasound uses sound waves to create pictures inside your body. Elastography goes a step further by measuring how stiff tissues are. The aim is to see if measuring the stiffness of a bladder tumour can help doctors more accurately tell whether it's a less aggressive or more aggressive type before surgery. Currently, this can sometimes be difficult to work out, meaning patients might have to wait for test results after an operation. If successful, this new method could help doctors make quicker, more informed decisions about treatment, potentially avoiding unnecessary chemotherapy or guiding treatment plans more precisely.

At a glance

Status

Recruiting

Sponsor

University Hospital, Tours

Enrolment target

Start

06 Feb 2024

Estimated completion

01 Feb 2025

Elastographic Measurement Intravesical Pressure Measurement

What is this study about?

When doctors suspect someone has a bladder tumour, they usually carry out tests like scans or a cystoscopy, where a thin camera is used to look inside the bladder. After this, a small operation called a transurethral resection helps confirm the diagnosis and remove the tumour. Sometimes, after this operation, a type of chemotherapy might be given directly into the bladder, but this depends on the type of tumour and if there are any complications.

Currently, it can be challenging to know exactly what type of bladder tumour someone has before the operation. This study is exploring a new way to get this information earlier using a special type of ultrasound called elastography. Regular ultrasound shows the size, number, and location of tumours, but elastography measures how stiff the tumour tissue is. Previous research in other parts of the body, like breast tumours, has shown that stiffness can indicate whether a tumour is more or less aggressive.

This research aims to see if the same is true for bladder tumours. By measuring the tumour's stiffness with this special ultrasound, while also keeping an eye on how full the bladder is, doctors hope to find a link between the tumour's stiffness and its type. If this method works, it could help doctors understand the tumour better before surgery, leading to more accurate and earlier treatment decisions.

Key takeaways

Exploring a new ultrasound method (elastography) for bladder tumours.
Aims to tell difference between tumour types by measuring stiffness.
Could help doctors make quicker, more accurate treatment plans.
Involves an extra, non-painful ultrasound scan before surgery.
Does not change your current treatment plan.
Contributes to future improvements in bladder cancer diagnosis.

Who may be eligible?

To be considered for this study, you need to be an adult over 18 years old. You must have a bladder tumour that has been seen on a scan or camera test, and it needs to be at least 2 centimetres in size. You should also be preparing for your first surgery to remove the tumour.

There are some reasons why you wouldn't be able to join the study. These include if you have a very high body mass index (BMI over 30), if you currently have a tube (catheter) in your bladder, or if you've had surgery on your bladder or prostate before. Also, if you've previously had certain bladder treatments like BCG or Ametycine, or if you've had radiotherapy to your pelvis, you won't be able to take part.

Finally, if you've let it be known that you don't want your health information to be used for research, then this study wouldn't be suitable for you.

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 over 18 years old?
Do you have a bladder tumour at least 2cm wide, seen on a scan or camera test?
Are you having surgery to remove your bladder tumour for the first time?
Have you *not* had previous bladder or prostate surgery?
Have you *not* had certain bladder treatments (BCG/Ametycine) or radiotherapy to your pelvis?
Do you *not* have a current bladder catheter or a BMI over 30?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would have an extra ultrasound scan using the elastography technique. This scan will measure the stiffness of your bladder tumour. During this scan, the doctors will also monitor how full your bladder is, as this can affect the stiffness measurements. This extra scan would happen before you have your surgery to remove the tumour. The study team will then compare the stiffness measurements from the ultrasound with the results from your tumour after it's removed during surgery. There are no additional medications or long-term follow-up visits specifically for this study. The total duration of your active involvement would be the time it takes for this extra ultrasound scan before your planned surgery.

Potential risks and benefits

Participating in this study involves an additional ultrasound scan, which is generally considered safe and painless, with no known risks from the sound waves used. Potential benefits for you personally are limited, but you would be contributing valuable information that could help doctors diagnose and treat bladder tumours more effectively in the future, potentially leading to better outcomes for other patients. You are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

University hospital
Verified postcode
Tours, France· Recruiting

Common questions

What is elastography?

Elastography is a special type of ultrasound scan that measures how stiff your tissues are. It's like gently pressing on something to feel its firmness.

Why is 'stiffness' important for bladder tumours?

Doctors are trying to see if the stiffness of a bladder tumour can help them work out if it's a less serious or more serious type, which could help with treatment decisions.

Will this study change my planned treatment?

No, this study is for research purposes to gather information. Your doctors will continue to plan your treatment based on standard medical guidelines and tests. The results of this study aim to help future patients.

Is the elastography scan painful?

No, the elastography scan is an ultrasound, which is a non-invasive procedure, meaning it doesn't involve needles or cuts, and it should not be painful.

How long will the extra scan take?

The study involves an extra ultrasound scan before your planned surgery. The exact time isn't specified, but it would be a relatively short addition to your hospital visit.

How to find out more

Franck BRUYERE

f.bruyere@chu-tours.fr 247474372 Official trial record

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