A study looking at MRI scans to find out who is more likely to have side effects from brain radiotherapy (BRITER)
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
Cancer type:
Status:
Phase:
This study is for people who are going to have radiotherapy for a type of primary brain tumour called glioblastoma.
It is for people aged 65 or older.
More about this trial
Glioblastoma multiforme (GBM) is the most common type of primary brain tumour in adults. A common treatment for GBM is radiotherapy. But brain radiotherapy can have severe side effects, especially if you are older than 65.
Side effects of brain radiotherapy include:
- tiredness
- feeling or being sick
- worsening of your brain tumour symptoms
Not everyone who has brain radiotherapy has severe side effects. So the researchers in the study want to find out whether MRI scans can help to tell who will have side effects from radiotherapy.
Everyone taking part in this study completes quality of life questionnaires and will have an MRI scan before radiotherapy. The radiotherapy you have is the same as if you weren’t taking part in this study.
The main aim of this study is to find out whether MRI scans can help to tell who will have side effects from brain radiotherapy.
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:
- have a newly diagnosed glioblastoma multiforme (GBM)
- are going to have radiotherapy to the brain
- are able and willing to have an MRI scan
- understand English and can complete questionnaires
- are aged 65 or older
Who can’t take part
You cannot join this study if you are taking part in another trial looking at a new drug.
Trial design
This is an observational study. Researchers hope that up to 120 people from the UK will agree to take part.
Everyone taking part completes quality of life questionnaires. The questionnaires ask about how you have been feeling and whether you have had any problems.
The study team will look at the MRI scans you had during diagnosis. They check whether they can use these scans for their research. You may need to have another MRI scan before the start of your radiotherapy treatment.
The MRI scan can take up to 10 minutes longer than a normal MRI scan. This is because the study team want to take some extra pictures.
The radiotherapy treatment you have is the same as if you weren’t taking part in this trial. You usually have treatment every day, Monday to Friday, for 3 to 6 weeks. Your doctor can tell you how many treatments you will have.
You complete more questionnaires at the end of treatment. You complete them:
- 3 to 5 weeks after radiotherapy
- 7 to 9 weeks after radiotherapy
Hospital visits
The radiotherapy treatment you have is part of your routine care. You complete the questionnaires when you are already at the hospital for routine appointments.
You might have 1 extra hospital visit if you need to have an MRI scan.
Side effects
The trial team doesn’t think you will have any side effects from completing the questionnaires. Answering questions about how a brain tumour has affected your quality of life can be upsetting. The study team will offer you support if you do find it upsetting.
MRI scans are very safe, but you might have some side effects such as:
- bruising and swelling around the area where the radiographers put a needle into a vein in your arm to give you the dye (contrast medium)
- an allergic reaction to the dye
You might also have side effects from radiotherapy.
Recruitment start:
Recruitment end:
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.
Chief Investigator
Dr Cressida Lorimer
Supported by
Brighton and Sussex University Hospitals Trust
The Sussex Cancer Fund
brainstrust
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040