A Phase 1 Single Center Clinical Trial Evaluating Safety of 5-Aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy (SDT) in Patients With Newly Diagnosed High-Grade Glioma (HGG) Prior to Resection and Standard Adjuvant Therapy
This study is investigating a new treatment approach for people recently diagnosed with a serious type of brain tumour called high-grade glioma. The treatment involves a medicine called 5-Aminolevulinic Acid (5-ALA), also known as Gliolan, combined with ultrasound. This combination is designed to work together to target tumour cells. Before patients have surgery and their usual cancer treatments, researchers want to carefully check the safety of this new therapy. They will monitor for any side effects and see how well patients tolerate the treatment over a short period. This is an early-stage study to understand if the treatment is safe enough to be explored further.
At a glance
What is this study about?
This research study is about finding new and safer ways to treat a serious type of brain tumour called high-grade glioma. When doctors diagnose this kind of tumour, they usually recommend surgery and other treatments. This study is testing a new approach before those usual treatments begin.
The new treatment involves giving a special medicine called 5-Aminolevulinic Acid (5-ALA), also known as Gliolan, which has been used in other ways to help doctors see tumours better during surgery. In this study, it's being combined with ultrasound. The aim is for the medicine to make the tumour cells sensitive to light from the ultrasound, which could then help to destroy them. This is a very early study, and the main goal is to carefully check how safe this combined treatment is and if people can tolerate it well.
Researchers will be looking closely for any side effects and how the treatment affects the tumour and surrounding brain tissue. They will also look at changes in the tumour on MRI scans and examine tissue samples to see how the treatment has worked at a cellular level. All of this information will help doctors understand if this new treatment could be a helpful option for future patients with high-grade glioma.
Key takeaways
- This is a study for newly diagnosed high-grade glioma.
- It tests a new treatment combining medicine (Gliolan) and ultrasound.
- The main goal is to check how safe the treatment is.
- You'll be closely monitored for side effects for 28 days.
- Participation is before your planned surgery and other standard care.
Who may be eligible?
To join this study, people must be at least 18 years old. Both men and women can take part.
You would need to have been recently diagnosed with high-grade glioma, which is a specific type of brain tumour. The treatment in this study happens before you have your surgery or any other standard cancer treatments.
The study team will check your full medical history and perform some tests to make sure that taking part is safe for you and that you meet all the specific requirements of the study.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you recently been diagnosed with high-grade glioma?
- Are you able to have the study treatment before your surgery?
- Are you generally well enough to take part in a study?
What does participation involve?
If you decide to take part in this study, the main focus will be on monitoring your safety. You would receive the study treatment, which involves taking the Gliolan solution and then having the ultrasound treatment.
After receiving the treatment, doctors and nurses will closely monitor you for any side effects for 28 days. This will involve regular check-ups, including physical examinations and detailed neurological checks to assess your brain and nervous system. You'll also have blood tests to check your general health, blood counts, and how your liver is working. Any changes noticed during these checks will be carefully recorded.
Before the treatment and after, you'll have MRI scans to see if there are any changes in the tumour, such as its size or how it affects the surrounding tissues. If you have surgery after the study treatment, doctors may also look at tissue samples from the tumour to see how the treatment has worked at a cellular level. All monitoring will conclude 28 days after you receive the study treatment.
Potential risks and benefits
Locations (1)
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Common questions
What is high-grade glioma?
It's a serious type of brain tumour that grows quite quickly.
What is Gliolan?
It's a medicine used in this study that, when combined with ultrasound, might help treat the tumour cells.
Will this treatment cure my cancer?
This is an early safety study, so we don't know yet if it will cure cancer. The goal is to see if it's safe enough to study further.
How long will I be in the study?
You will be closely monitored for 28 days after receiving the study treatment.
Can I still have my regular surgery?
Yes, this study treatment happens before your planned surgery and other standard care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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