SPRAYDYE-Trial - A phase I/II study to assess the efficacy, safety and tolerability of topically applied 6qc-ICG, a cathepsin-activatable fluorescent probe, for real-time intraoperative resection margin assessment in breast conserving surgery
This study is investigating a new kind of dye that surgeons can apply to breast tissue during an operation for breast cancer. The aim is to help them identify any remaining cancer cells in 'real-time,' meaning as they are performing the surgery. By making these cells glow, the dye could help surgeons ensure all cancerous tissue is removed, reducing the chance of cancer coming back or needing another operation. Researchers will be checking if this dye is safe to use and how well it works. This is an early-stage study, meaning it’s one of the first times this dye is being tested in people.
At a glance
What is this study about?
When someone has surgery for breast cancer to remove the tumour, the surgeon's main goal is to take out all the cancer cells. This can be tricky because sometimes tiny bits of cancer aren't easily visible to the naked eye. If cancer cells are left behind, the patient might need another operation, or other treatments.
This study is testing a special dye called 6qc-ICG. The idea is that this dye is applied to the area where the tumour was removed. This dye is designed to specifically stick to and light up any remaining cancer cells, making them glow under a special light. This 'glowing' would tell the surgeon exactly where those leftover cancer cells are, helping them to remove them then and there during the original surgery.
The main purpose of this research is to see if this dye is safe for people to use and whether it effectively helps surgeons identify any cancer cells that might have been missed in the first attempt. If successful, this could help many people with breast cancer by improving the accuracy of surgery and potentially reducing the need for further operations down the line. It's an important step in making breast cancer surgery as effective as possible.
Key takeaways
- A new dye is being tested to help surgeons see breast cancer cells better during surgery.
- The study aims to improve accuracy and potentially reduce the need for repeat operations.
- It's an early-stage study, checking safety and how well the dye works.
- Participation involves receiving the dye (or placebo) and regular health checks.
- You have the right to leave the study at any point.
Who may be eligible?
To be part of this study, you would need to be an adult, aged 18 or older. There is no upper age limit, and the study is open to both men and women undergoing breast cancer surgery.
More specific details about your particular breast cancer diagnosis, overall health, and any other medications you are taking would also be considered by the study doctors to make sure the study is a good fit for you and safe.
It's important to remember that not everyone who wants to join a clinical trial will be able to, as there are strict rules to protect participants and ensure the study results are clear.
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?
- Are you having surgery for breast cancer?
- Are you able to attend follow-up appointments?
- Are you willing to have blood tests, urine tests, and heart recordings?
- Are you comfortable potentially receiving a placebo instead of the active dye?
What does participation involve?
If you decide to take part in this study, you would be given the special dye (or a placebo, which is an inactive substance) during your breast cancer surgery. The doctors would carefully check the area where the dye was applied. Throughout the study, the research team would closely monitor your health. This would involve regular checks of your vital signs, like your pulse and blood pressure, as well as blood and urine tests. You would also have heart recordings (ECGs) and be asked about any pain, itching, or other side effects you might experience. The total duration of your participation would depend on the study schedule, involving several appointments for these checks and possibly follow-up to see how your wound heals.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is the main goal of this study?
The main goal is to see if a special dye can help surgeons find and remove all breast cancer cells during an operation, making the surgery more accurate.
Will I definitely get the special dye?
You might get the special dye or a placebo (an inactive substance), as this is a common way to test new treatments fairly.
What kind of tests will I have if I join?
You'll have regular checks like blood pressure, pulse, blood tests, urine tests, and heart recordings (ECGs). You'll also be asked about how you feel.
Is this dye already widely used?
No, this is an early-stage study (Phase I/II), meaning it's one of the first times this dye is being tested in people to see if it's safe and effective.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, for any reason, and it will not affect your medical 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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