A study to see if a drug called Gliolan can help to confirm the grade of a brain tumour during surgery (GALA-BIDD)

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Brain (and spinal cord) tumours

Status:

Closed

Phase:

Other

This study is looking at a drug called Gliolan to see if it can help surgeons see what grade a brain tumour is during surgery. The people taking part are having surgery to remove a type of brain tumour called a glioma.

More about this trial

Gliomas are graded according to how fast they are likely to grow. Low grade tumours (grade 1 or 2) grow more slowly than high grade tumours (grade 3 or 4). When you have surgery to remove a brain tumour, your surgeon sends samples to the laboratory to find out what grade the tumour is. Knowing the grade of the tumour can affect decisions about whether other treatments may help you.

Researchers are looking for a way to confirm whether a tumour is high grade or low grade during surgery. In this study, they are looking at a drug called Gliolan that is already used during surgery to remove brain tumours.

Gliolan is a dye that can make brain tumour cells glow red under ultra violet light. During surgery, surgeons can use it to check they are removing as much brain tumour as possible. The aim of this study is to see if Gliolan can also help to show if a tumour is high grade.

Taking part in this study will not affect the treatment you have after surgery. But the researchers hope the results will help to improve treatment for people who have a brain tumour in the future.

Who can enter

You may be able to join this study if all of the following apply.

Your case has been reviewed by a multi disciplinary team and you are going to have surgery to remove a brain tumour
An MRI scan suggests the tumour is a grade 2, 3 or 4 glioma
Your surgeon intends to use Gliolan and an ultra violet light during surgery to try to show the brain tumour cells
You are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
You are at least 16 years old

You cannot join this study if any of these apply. You

Have already had brain surgery (including a biopsy) or radiotherapy to your brain
Are currently having any other anti cancer treatment (apart from steroids)
Can’t have Gliolan for some reason such as allergies (your doctor can advise you about this)
Have liver disease that is causing symptoms
Have a low number of cells called platelets that help your blood to clot (your doctor can advise you about this)
Have had any other cancer in the last 5 years apart from a very early cancer (carcinoma in situ ) or non melanoma skin cancer that was successfully treated
Are pregnant or breastfeeding

Trial design

The researchers need about 80 people to join this study. Everybody taking part is having surgery to remove a glioma and their surgeon is intending to use Gliolan to try and make the brain tumour cells glow red under ultra violet light.

You drink Gliolan as a liquid 3 to 5 hours before having your surgery as planned. Tissue that is removed during surgery is looked at in the laboratory to see if your tumour is high grade or low grade. Your diagnosis will be confirmed up to 4 weeks after surgery.

The study team will look at how many people whose brain tumour cells glowed red under the ultra violet light are diagnosed with a high grade glioma. They will also look at the number of people diagnosed with a high grade glioma whose cells didn’t glow red under the light.

All the information collected about you in this study will be kept confidential Open a glossary item .