Last year in the UK over 60,000 cancer patients enrolled on clinical trials aimed at improving cancer treatments and making them available to all.
A study looking at a type of MRI scan to assess how well bladder cancer treatment is working early on (MARBLE)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This study is looking at some new scans to see if they can show how well treatment has worked in people having chemotherapy before surgery or radiotherapy for bladder cancer.
More about this trial
MRI scans are important scans for doctors wanting to look at cancer. Researchers in this study have developed some new ways of looking at tumours using a type of MRI scan called a functional MRI scan (fMRI). They believe that fMRI may be better at showing how well cancer treatment is working early on. They now want to see how reliable these scans are when looking at bladder cancer.
They are also looking at how well a new type of PET-CT scan can show up bladder cancer and give them more information about it. This scan is called FLT PET-CT.
People having chemotherapy before radiotherapy or surgery for bladder cancer can join this study. The study team will scan people at the early stages of their treatment. They will see how well these new scans pick up any response to treatment.
They will also look at blood and tissue samples to see if there is a relationship between these and the new scan results. And compare results of these new scans with the CT scan you will have as part of your routine treatment.
The aim of this study is to see if new scans are better than CT scans at showing how a cancer is responding to treatment early on. You are not likely to get any direct benefit from taking part in this study. But the results of the scans will be used to help people with bladder cancer in the future.
Who can enter
You may be able to enter this study if
- You have bladder cancer that has grown into the bladder muscle
- Your bladder cancer has not grown as far as the wall of the
pelvisor tummy, and no cancer cells have spread as far as the lymph nodesin your groin(your cancer is stages T2 to T4a, and N0 to N2)
- You have had surgery to remove tumours from your bladder, but tests show that you still have some cancer left
- You are due to have 3 or 4 cycles of chemotherapy to shrink the cancer before having
chemoradiationor surgery to remove all or part of your bladder
- You have satisfactory blood test results
- You are at least 18 years old
You cannot enter this study if
- Your cancer has spread to another part of your body (stage M1)
- You can’t have MRI scans, for example because you have some metal in your body, have a
pacemakeror you cannot cope with small spaces
- You have had any other cancer in the last 5 years, unless it was a very early stage and has been successfully treated – the study team can advise you about this
- You are pregnant or breastfeeding
This feasibility study will recruit between 15 and 20 people. Everyone taking part will have 3 fMRI scans. You have the scans
- Before you start chemotherapy
- 2 weeks after your first dose of chemotherapy
- 2 weeks after the first dose of chemotherapy in your second cycle of treatment
The team would also like to take a blood sample and a sample of the cancer tissue taken when you were diagnosed. And, a sample of tissue if you are having surgery after your chemotherapy.
They will test these samples to see if there is a relationship with the scan pictures.
The team may ask if you would be happy to take part in a mini study (sub study). This is to see if a type of PET-CT scan called FLT PET-CT can show up bladder tumours and give more information about them. This scan uses a
If you agree, you have the scan before you start chemotherapy. When you arrive, you have some fluid through a drip into a vein, or a drink of water. You have the FLT injection into a vein in your arm or hand. You then lie down to let the cancer cells take up the FLT.
The PET CT scan takes up to 45 minutes. After a break you have another scan, which takes 30 minutes. As part of the scans you have a drug that helps flush the FLT through your system. So the team will ask you to empty your bladder before your third scan. This last scan takes 5 minutes. The team will compare the scan information with all the other information they have collected from the main study.
You make 3 extra visits to hospital for your fMRI scans. If you agree to take part in the sub study, you also come to hospital for the FLT PET CT scan.
You will give your study blood sample when you come to hospital for your routine blood tests.
You should not have any side effects from the fMRI scans. But if the fMRI scans show that your cancer is active after your chemotherapy, the team may speak to the surgeons and think about arranging more tests, or changing your treatment.
If you have the FLT PET CT scan for the sub study, you will be exposed to a small amount of radiation from the FLT injection. The team do not think that this will cause any problems.
You have a drug called furosemide in the sub study to help flush the FLT out of your body. You may need to pass urine often for a few hours afterwards having this.
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Dr John Frew
Experimental Cancer Medicine Centre (ECMC)
Medical Research Council (MRC)
NIHR Clinical Research Network: Cancer
The Newcastle upon Tyne Hospitals NHS Foundation Trust