A study to improve the diagnosis of bladder cancer (BladderPath Study)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Bladder cancer

Status:

Closed

Phase:

Phase 2

This study is looking at using an MRI scan to diagnose bladder cancer that has grown into the muscle.

More about this trial

There are several tests you might have to diagnose suspected bladder cancer. One test uses a camera to look inside the bladder. This is a cystoscopy.

When a suspicious lesion is found the surgeon removes it through the urethra. This is the tube that connects the bladder to the outside of the body. This procedure is a trans urethral resection of bladder tumour (TURBT). They take tissue samples (biopsies) and see how far the cancer has grown into the muscle wall. This is to confirm the stage of the cancer and work out the best treatment.

Invasive bladder cancer is when the cancer has grown into the surrounding muscle layer of the bladder. Doctors worry that waiting to have a TURBT to stage cancer is delaying treatment for these people. So, researchers are looking for quicker ways to diagnose and stage the cancer.

In this study they are using a Magnetic Resonance Imaging (MRI scan). Some people will follow the standard way that doctors diagnose bladder cancer. And some will follow the newer plan that includes having an MRI scan.

The main aims of the study are to find out:

how accurate MRI scans are at diagnosing invasive bladder
if the scan reduces treatment waiting times for people with invasive bladder cancer
if the scan avoids unnecessary surgery

Please note: you might not benefit from taking part in this study. But the information obtained may result in changes in the future diagnosis, treatment and follow up of people with bladder cancer.

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study team if you are unsure about any of these. They will be able to advise you.

Who can take part

You may be able to join this study if all of the following apply.

You:

are having tests for suspected bladder cancer
have had a test to look inside the bladder and you now need to have TURBT
are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply.

You:

are unable to or unwilling to have an MRI scan
are unsuitable or unfit to have a TURBT
have had bladder cancer in the past
are pregnant or breastfeeding

Trial design

This study is taking place in the UK. The researchers need 150 people to join.

It is a randomised study. You are put into groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

Everyone has a test to look inside the bladder as usual. If the doctor sees a suspicious lesion they’ll ask if you are willing to join the main study. You are then put into 1 of the following 2 groups. You follow:

the standard way of diagnosing bladder cancer (pathway 1)
the newer way of diagnosing bladder cancer (pathway 2). This group is then divided into those who:
- probably don’t have cancer in the muscle (you have a standard TURBT)
- possibly have cancer in the muscle (you have an MRI of the bladder)
  
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The standard way of diagnosing (pathway 1)

This involves:

a TURBT to remove the suspicious lesion
a specialist doctor examining tissue samples to check for bladder cancer and if it has grown into the muscle wall

You might then have further treatment to stop it coming back if the cancer hasn’t spread into the muscle layer. Your doctor will tell you more about this.

You have treatment if the TURBT shows the cancer has spread into the lining. The possible treatment options include chemotherapy, radiotherapy or surgery. These are the same treatments you would have if you hadn’t joined the study.

The newer way of diagnosing (pathway 2)

The doctors examine the tissue sample they took when you had a cystoscopy. From this, they’ll predict if the cancer has grown into the muscle or not. We know from earlier trials that this is accurate in 9 out of 10 people (90%).

You have:

an MRI scan if doctors predict there is cancer in the muscle
a TURBT if doctors predict there isn’t cancer in the muscle

There is a small chance the MRI scan result will show that the cancer isn’t in the muscle. You’ll have a TURBT if this happens and further treatment if necessary. Your doctor will tell you more about this.

Those who have cancer that has grown into the muscle have treatment. These are usually the treatment options that you would have if you hadn’t joined the trial. These include:

chemotherapy
radiotherapy
surgery

Your doctor will tell you more about this.

Samples for research

You give some extra urine and blood samples. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to find out more about bladder cancer.

The doctors will ask permission to store leftover tissue samples for future research. You do not have to agree to any of your urine, blood or tissue samples being used for future research if you don’t want to. You can still take part in the study.

Quality of life

The study team will ask you to fill in a questionnaire before you have your tests and at set times during the study. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see a doctor and have some tests before you can take part. These include:

blood samples
urine sample

You might have 1 or 2 extra hospital appointments if you are in the MRI scan group.

You won’t have extra hospital visits at the end of the study. The study team will follow you up at your routine hospital appointments to see how you are getting on.

Side effects

No method of assessing bladder cancer is 100% accurate. For both groups, there is a risk of over or under treatment.

In the standard diagnosis group, there is a small risk that the initial TURBT can show that the tumour hadn’t grown into the muscle wall. But it had. This means these people don't have enough initial treatment or treatment is delayed.

In the newer way of diagnosing there is a small risk of over treatment. This means the scan over estimates the cancer is in the muscle layer of the bladder. So, you have might have treatment that you don’t need. Researchers haven’t done this type of study before. But they predict this might happen in under 5 out of every 100 people (5%).

Having an MRI scan is a safe test. There is a very small chance that you might have an allergic reaction to the contrast medium you have to show up your body organs more clearly. But the person doing the test will keep a close eye on you and treat any problems straight away.