An open-label, non-randomized, single dose, phase II trial of FG001 (an optical imaging agent) for localization of Meningiomas or presumed Low- Grade Gliomas scheduled for neurosurgery.
This study is looking at a new dye, FG001, to see how well it helps surgeons find certain brain tumours during an operation. The tumours involved are meningiomas, which grow from the lining of the brain, and presumed low-grade gliomas, which are slower-growing brain tumours. The dye is designed to light up tumour tissue, making it easier to see exactly where it is. Researchers want to know how effective the dye is at highlighting all of the tumour, including bits attached to the dura (the brain's outer covering) for meningiomas. They will compare what they see with the dye to what they find when they test the tissue under a microscope afterwards. Safety is also very important, so they'll be checking for any side effects and how the body reacts to the dye.
At a glance
What is this study about?
When someone needs brain surgery for a tumour like a meningioma or a low-grade glioma, it's really important for surgeons to remove as much of the tumour as possible. However, sometimes tumour tissue can be hard to see clearly with the naked eye, even for experienced surgeons. This study is testing a new special dye called FG001, which is given to patients before their operation. The idea is that this dye will make the tumour tissue light up, helping surgeons identify it more easily during the surgery.
This is a ‘Phase II’ study, meaning it's one of the earlier steps in testing a new treatment. The main goal is to see how accurate FG001 is at showing all the tumour cells. For meningiomas, they also want to check if it helps spot tumour parts attached to the dura, the protective layer around the brain. After the surgery, the removed tissue is looked at under a microscope (this is called histology) to see if what the dye highlighted matches the actual tumour cells.
This research is important because if FG001 works well, it could help surgeons remove more of the tumour while being careful not to damage healthy brain tissue. This could potentially lead to better outcomes for patients. As part of the study, doctors will also carefully monitor how patients react to the dye, checking for any side effects to make sure it's safe to use.
Key takeaways
- This study is testing a special dye, FG001, to help surgeons find brain tumours during operations.
- It's for people with meningiomas or presumed low-grade gliomas who are having surgery.
- The main goal is to see how accurately the dye highlights tumour tissue compared to microscopic tests.
- Researchers will also carefully check for any side effects to make sure the dye is safe.
- Taking part means receiving the dye once and having your health closely monitored.
Who may be eligible?
To be able to take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
More specifically, you would need to be scheduled for brain surgery because you have either a meningioma or a brain tumour that doctors suspect is a low-grade glioma. The study doctors will have a more detailed list of health requirements that they will check to make sure the study is a good fit for you and safe for your health.
It's important to remember that strict rules are in place for who can join a study like this. These rules are there to protect your safety and to make sure the results of the study are clear and accurate. Your doctor can discuss these with you in detail.
- Are you 18 years old or older?
- Are you scheduled to have brain surgery for a meningioma or a suspected low-grade glioma?
- Are you able to provide your consent (agreement) to take part?
- Have you discussed this study with your main doctor?
- Do you have any other serious health conditions that might prevent you from joining?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive a single dose of the special FG001 dye before your scheduled brain surgery. The dye is given once, and its effects on helping surgeons see the tumour are checked during your operation.
After receiving the dye and during your surgery, the research team will collect information related to whether the dye successfully highlighted the tumour. They will also keep a close eye on your health throughout your hospital stay. This includes monitoring for any unexpected side effects (called 'adverse events'), checking your blood tests, doing heart checks (ECG), and regularly monitoring your vital signs like blood pressure and heart rate. You would have follow-up checks after your surgery, which might involve a clinic visit or phone calls, to make sure you are recovering well and to check for any delayed side effects. The total duration of your participation in the study will depend on your recovery and when all the necessary follow-up checks are completed.
Potential risks and benefits
Locations (1)
- —Denmark
Common questions
What is FG001?
FG001 is a special dye that doctors are testing to see if it helps them see certain brain tumours more clearly during surgery.
What kinds of tumours is this study looking at?
This study focuses on meningiomas and presumed low-grade gliomas, which are types of brain tumours.
Why is this dye important for surgery?
The dye is hoped to make tumour tissue 'light up', helping surgeons find and remove as much of the tumour as possible during your operation.
Is FG001 a new treatment for my tumour?
No, FG001 is not a treatment to cure your tumour. It’s an imaging agent, meaning it helps doctors see the tumour better during surgery.
Will I get FG001 if I join the study?
Yes, if you join the study, you would receive a single dose of the FG001 dye before your scheduled brain surgery.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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