Taking part in the FUTURE-GB trial

WHAT WILL HAPPEN IF I TAKE PART?

Initial assessment

If you are happy to take part in this study, a researcher will ask you some simple questions and check your medical history to confirm that you are eligible.

If you are eligible and wish to participate, you will be asked to sign and date a consent form for the study. We will also ask you to complete some short questionnaires about your health, the activities you are able to carry out, and about your quality of life. These questionnaires should take you no more than 10-15 minutes to complete.

 

Imaging (scans) allocation

You will then be randomly allocated to an imaging group by a computer, which has no information about you as an individual, i.e. allocation is by chance. You will have an equal chance of being allocated to either group, like the toss of a coin. There is a 50% chance that you will be put into the group in which the additional imaging tools will be used during your operation, in addition to the standard techniques, and a 50% chance that you will be in the group where the surgeon uses the present, standard imaging tools.

The random allocation is important because this way, we can test the different imaging tools fairly and nobody can influence into which group you are placed. If you enrol in the study, your healthcare and research teams will not be able to affect which imaging tools will get used in your operation and you will not be able to choose.

You will not be aware into which arm of the study you have been allocated, just in case you answer the questionnaires differently based on the imaging used in your operation. 

 

WHAT TECHNOLOGIES WILL BE USED IN MY OPERATION?

Standard care

If you are allocated to the standard techniques arm of the study, your surgeon will use the standard NHS imaging tools.

You will have an MRI scan before your operation. This can be used during the surgery to help your surgeon identify where your brain tumour is located, and what brain structures are close by. MRI stands for Magnetic Resonance Imaging. It is a type of scan that uses strong magnetic fields to produce detailed images. It is used for brain tumour surgery to obtain detailed images of your brain and specifically your brain tumour. There is no risk of radiation exposure.

This is combined with use of a chemical called 5-aminolevulinic acid (5-ALA), which is a drink taken a few hours before surgery. This allows the tumour cells to light up pink, when a blue light is shone on them during surgery. This has been shown to help surgeons remove more of the brain tumour, as they are able to see better the edges of the tumour and differentiate it from the surrounding normal brain. This makes sure as much of the tumour is removed as is possible, but it can never usually be totally removed.
 

Newer technologies

If you are allocated to the group that will use the additional imaging tools, your surgeon will undertake all of what is listed above, together with the additional imaging tools. You will have a slightly longer MRI scan (additional 5 minutes) and have the imaging outlined below also undertaken as part of your operation.

1) Diffusion Tensor Imaging (DTI) is an MRI technology which allows the surgeons to have a scan of all the nerve fibres which are involved in movement, speech etc. around a tumour. This means that when removing the tumour the surgeon knows more easily where these are based on your DTI scan and can avoid them. 

2) Intraoperative Ultrasound is a technology that uses high frequency sound waves to create an image of the brain tumour during the operation. The ultrasound provides “live” pictures of your tumour as surgery progresses and tumour is removed. The surgeon can use this as many times as necessary during your surgery. The ultrasound is the same as that used to provide a picture of a baby inside a pregnant woman.

Both these technologies are safe and have been used in brain tumour surgery for a number of years. Your surgeon is familiar with their use and has used them during surgery. However, the benefit of using these two new technologies together, in addition to the present “standard of care” surgery, has not been scientifically tested, or formally assessed. There are no extra drugs or chemicals used.

 

FURTHER POSSIBLE CONTACTS

A researcher from the trial coordinating team may visit while you are having your operation so that we can check how the surgery is being undertaken. We will always check that you are happy for this to happen. If not, the researcher will not come into your operation. At the end of the study, we will report how well the treatments were delivered as it is important we fully understand this process.

Please note, no-one can ever be identified in any public report about the study.

 

WHAT WILL HAPPEN AFTER MY OPERATION IN FUTURE-GB?

As part of the study you will be asked to complete some questionnaires. The questionnaires ask about you, your health and activity, and your quality of life. We ask that you complete the questionnaires when you leave hospital, at 6 and 12 weeks after surgery, and then every 3 months, for a maximum of 2 years. These time points are when you would usually be coming back to the hospital for routine NHS care, and it may be possible to complete them at these appointments. However, they can be completed online or taken away and posted back to us.

We also would ask you to nominate a good friend/relative/partner to complete the same questionnaires as we would ask you. This is in case you have any difficulty answering the questionnaires and so we can see if others can accurately tell us about your health. 

Questionnaires should take no more than 15 minutes to complete on paper/online, or about 25 minutes over the telephone.  (You will generally receive your questionnaires to complete whilst you are at the hospital either for your surgery or for outpatient appointments).

 

WHAT ARE THE BENEFITS AND RISKS OF TAKING PART IN THIS STUDY?

For those that take part in the study, your operation will be conducted by the same surgeon/surgical team whom you have already seen.

We hope the information from this study will answer the question:

Which imaging tools should be used by surgeons when removing a glioblastoma, to offer the highest chance of removing as much of the tumour as possible without causing functional problems, and therefore keeping a good quality of life?

We cannot promise the study will help you directly, but the information we get has the potential to be of benefit, potentially allowing more of your tumour to be removed safely.

The risks relating to the brain tumour surgery itself will be discussed with you in detail as part of the standard, routine consent for an operation. We do not think that being part of this study will change any of the risks of the operation but this is one of the things we be will be studying.

We are undertaking this study because the extra imaging tools add significant costs to NHS treatment, and therefore we have also been funded to identify whether they provide a real benefit for people with brain tumours.

People sometimes feel uncomfortable answering certain questions about their health, or may be unable to answer. If you, or the person you nominate to answer for you, feel uncomfortable at any point, then you do not have to answer the questions.

We are not able to pay travel expenses for you to attend your follow-up sessions, however any research questions asked will be as part of your routine out-patient follow-up appointments.