A study looking at a new type of MRI scan to predict if, where and when glioblastoma might come back (PRaM-GBM)
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 with a type of brain tumour called 
. The researchers are looking at a special MRI scan called DTI-MRI. The study team would like to see if this type of scan can help to predict if, where and when glioblastoma comes back after treatment.
Please note, the main part of this study is now closed and the team don’t need any more people to take part. The PET-CT scan sub study is open for people to join. There is information about this in the trial design section of the summary.
Cancer Research UK supports this study.
More about this trial
Glioblastoma belongs to a group of brain tumours called gliomas. Doctors sometimes call glioblastoma a grade 4 astrocytoma.
The treatment for glioblastoma is usually surgery to remove as much of the tumour as possible. After surgery, you normally have radiotherapy and chemotherapy.
As part of your treatment for glioblastoma you have MRI scans to take pictures of your brain. These pictures help your doctors to look at:
- the size of the tumour
- where the tumour is
- how well the treatment is going
Diffusion tensor imaging (DTI) is a special type of MRI scan. The researchers hope that it shows brain in more detail.
The main aim of the study is to see if using DTI-MRI scans helps doctors predict if, when and where glioblastoma comes back during and after treatment.
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 diagnosis of high grade glioma
- are able to have surgery and your surgeon thinks that more than 90% of the tumour can be removed
- are going to have radiotherapy and chemotherapy after surgery – this combination is called the Stupp Regime
- can't carry out heavy physical work, but can do anything else (WHO performance status of 0 or 1)
- are at least 16 years old
Who can’t take part
You cannot join this study if any of these apply. You:
- are taking part in another trial involving treatment for your tumour
- are not able to have an MRI scan for any reason, for example you have metal implants such as a
pacemaker , surgical clips, pins or plates or cochlear implants (for deafness), you have a fear of being in closed spaces or your kidney’s don’t work very well - are known to be sensitive to the injection given during an MRI scan (known as
contrast medium )
| There is also a sub study looking at PET-CT scans as part of PRaM-GBM. If you are pregnant, you cannot take part in the PET-CT study. Your team will give you more information. |
Trial design
Main study - this part of the study is now closed.
The researchers would like 95 people to take part.
Everyone who takes part has a DTI-MRI scan:
- before surgery
- before starting radiotherapy – this should be within 6 weeks
You have treatment and any follow up appointments as usual. Your doctor will tell you exactly what to expect.
You have other MRI or CT scans throughout your treatment as usual. Your doctor will let you know when these are likely to be.
The study ends when have your follow up scan, 2 years after joining. You can no longer take part if your cancer comes back during this time. Your doctor will let you know the new treatment plan if this happens.
Once you have finished taking part in the study, but while the study is still ongoing, the researchers would like to continue to collect information about your health. This would be from your hospital medical notes.
Samples for research
The study team will ask your permission to store a sample of tissue they remove when you have surgery. Scientists might use this in the future for research into brain tumours.
You do not have to agree to give these samples for research. You can still take part in the study and your care will not be affected.
PET sub study – this part of the study is open
The researchers are also looking at a type of PET-CT scan called an amino acid PET-CT. Research has shown that this type of scan can show the area to be removed during surgery when your surgeon uses a type of dye called 5-ALA.
The researchers would like around 35 people to take part.
The aim of the sub study is to see if it helps to have the PET-CT scan as well as the DTI-MRI. And to compare what can be seen from these two different scans.
You have an amino acid PET-CT before surgery. This is at the same time as a DTI-MRI.
During surgery, you have samples () taken from areas highlighted on your DTI-MRI and PET-CT scans. The doctors can then compare the pictures from the scans to the tissue samples taken.
Hospital visits
Depending on your local hospital you either:
- do not have any extra visits to the clinic or hospital for this study
- have one extra visit to the hospital for the DTI-MRI scan before you start radiotherapy
The other DTI-MRI scans replace the usual scan you would have at that time. Each DTI-MRI scan usually takes under an hour.
Side effects
An MRI scan is very safe and doesn’t use radiation.
Having a DTI-MRI takes slightly longer than a standard MRI scan. So, you will need to lie in the scanning machine for a little longer.
A PET-CT scan is a safe test for most people. But like all medical tests it has some risks. Your doctor and radiographer make sure the benefits of having the test outweigh these risks.
Exposure to radiation during a PET-CT scan can slightly increase your risk of developing cancer in the future. Talk to your doctor if this worries you. Rarely, people have an allergic reaction to the radioactive tracer. This most often starts with weakness, sweating and difficulty breathing. Tell your radiographer immediately if you feel unwell.
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
Mr Stephen J Price
Supported by
Cancer Research UK
University of Cambridge
Cambridge University Hospitals
National Institute of Health Research
Other information
This is Cancer Research UK trial number CRUK/A19732.
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
