"He went through six operations and was placed on a clinical trial so he could try new treatments.”
A trial looking at ultrasound and diffusion tensor imaging during surgery for glioblastoma (FUTURE-GB)
This trial is looking at how useful it is to use ultrasound and diffusion tensor imaging during surgery to remove glioblastoma.
More about this trial
The aim of the surgery is to remove as much of the tumour as possible without causing too much damage to the surrounding nerve fibres. Damage to the surrounding nerve fibres can affect how you function. This includes your speech and movement.
To reduce the possible damage surgeons need to see where the nerve fibres are and where the tumour is.
So during surgery surgeons use scans such an
- diffusion tensor imaging
Ultrasound uses high frequency sound waves to produce a picture of the brain. When surgeons use it during surgery they get live in the moment pictures of the brain. The surgeon will be able to see how the surgery is going and when they have removed the tumour better.
Diffusion tensor imaging is similar to an MRI scan. It is done during the MRI scan you have before surgery. It shows the surgeons where the nerve fibres that control speech and movement are. So the surgeon will be able to see where these nerve fibres are around the tumour. This means that they can avoid them as much as possible while removing the tumour.
It is not known just how useful using these scans are. This is what researchers want to find out. In this trial everyone has the standard surgery to remove their glioblastoma.
There are 2 stages in this trial.
In the 1st stage everyone’s surgeon uses all these scans before and during the surgery. This is so the trial team can check how the surgeons use the scans.
The aim of this part of the trial is to find out whether it is possible to use these scans during surgery. The scans are ultrasound and diffusion tensor imaging
In the 2nd stage the surgeon will use ultrasound or diffusion tensor imaging in half the people taking part. They won’t use the scans in the other half.
The aims of stage 2 are to find out:
- whether adding ultrasound and diffusion tensor imaging improves the outcome of surgery
- how it affects
quality of life.
Please note you might not get any benefit from taking part in this trial. The information gained might help people with glioblastomas in the future.
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the study if you are unsure about any of these. They will be able to advise you.
Who can take part
There are 2 stages to this trial.
You may be able to join this trial if all of the following apply. You:
- are newly diagnosed with a glioblastoma (stage 4 astrocytoma)
- can have surgery to remove most or all of the tumour
- can have radiotherapy and temozolomide or chemotherapy and temozolomide after your surgery
- can have 5-ALA
- are 18 to 70 years old
You may be able to join stage 2 if all of the following also apply. You:
- can understand written English to fill in the trial questionnaires
- have a partner, relative or friend you can ask who understands written English and is willing to fill in the trial questionnaires. They must be between 18 and 75 years old.
Who can’t take part
You cannot join this trial if any of these apply. You:
- have a glioblastoma now that was previously a low-grade glioma or an anaplastic astrocytoma
- have glioblastoma in several areas of the brain (multifocal)
- have glioblastoma that has come back after previous treatment
- have glioblastoma that is in the midline, basal ganglia, cerebellum or brain stem. Your doctor will know which part of the brain your glioblastoma is.
- cannot have an MRI scan. This could be because you have metal in your body such as a pacemaker, surgical clips, pins or plates, cochlear implants or metal in any other part of the body.
There are 2 stages to this trial. Everyone in the trial has the standard surgery.
Stage 1 (IDEAL 2b study)
For stage 1 the team need 3 people to join from each site taking part. Everyone has standard surgery. In addition the surgeons use diffusion tensor imaging (DTI) before the operation and ultrasound imaging during the operation.
In this stage the team need 357 people to join.
This stage is a randomised trial. A computer puts you into a group. Neither you nor your doctor chooses which group you are in. And you will not know which group you are in before your surgery.
The 2 groups are:
- standard surgery using diffusion tensor imaging before the operation and ultrasound imaging during the operation
- standard surgery not using ultrasound or diffusion tensor imaging
Before surgery you have an MRI scan. The surgeon looks at this scan during surgery to see where the tumour is.
A few hours before surgery you have a drink with 5-ALA in it. 5-ALA is a chemical. It turns tumour cells pink when the surgeon shines a blue light on the brain.
Diffusion tensor imaging before surgery
Diffusion tensor imaging is similar to an MRI scan. When you have your MRI scan before surgery, you will have this scan at the same time.
The nerve fibres in the brain control many different functions such as movement and speech. The surgeon uses the diffusion tensor imaging to see where these nerve fibres are around the tumour. By doing so they could avoid these nerve fibres when removing the tumour.
Ultrasound during surgery
During your surgery the surgeon uses the ultrasound to create a picture of the brain. This can help them to better see where the tumour is. This gives them live pictures during the surgery. Which they use to remove the tumour.
Quality of life
You fill in questionnaires before you have surgery then:
- when you leave hospital
- 6 and 12 weeks after surgery
- then every 3 months for up to 2 years
The questions ask about:
- your general wellbeing
- what activities you can do
These are quality of life questionnaires.
For your partner, relative or friend
The team might ask if you have a partner, relative or friend who could help with their research.
They fill in questionnaires before you have surgery then:
- 5 days later or when you leave hospital
- 6 weeks later
- then every 3 months for up to 2 years
A member of the team will phone them. Or they can fill in the paper questionnaires or go online.
They don’t have to agree to do this study.
Everyone sees their doctor before agreeing to join the trial. This is to tell you about the trial.
You then see them at 5 days after surgery or when you are discharged from the hospital. This is to see how you are.
Before your surgery you have an MRI scan. You have another MRI scan within 3 days of your surgery. You then see the doctor at:
- 5 days after surgery or when you are discharged from hospital
- 6 weeks
- 3 months
- and then every 3 months up to 2 years
You have an MRI scan at 3 months and then every 3 months up to 2 years.
How to join a clinical trial
Professor Puneet Plaha
University of Oxford
NIHR Efficacy and Mechanism Evaluation (EME) Programme