FLUOPANC II: A performance study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for fluorescence-guided imaging to determine local extent and resectability during surgical resection of pancreatic ductal adenocarcinoma after neoadjuvant treatment.
This research is testing a new way to help surgeons operate on pancreatic cancer. They are using a special dye, SGM-101, which glows under a particular light. The idea is that when this dye is injected, it will attach to cancer cells, making them light up and guiding the surgeon to see the exact edges of the tumour, nearby lymph nodes, and any spread that might be hard to spot otherwise. This study focuses on people who have already had some treatment for their pancreatic cancer. It's hoped that better visibility during surgery will help doctors remove more of the cancer, improving outcomes for patients.
At a glance
What is this study about?
This clinical trial is exploring a new technique designed to help surgeons during operations for pancreatic cancer. After patients have already received treatments like chemotherapy or radiotherapy (called 'neoadjuvant treatment'), it can sometimes be difficult for surgeons to clearly see all of the cancer during an operation. This is because the previous treatments can change the way the cancer looks, making it hard to tell exactly where the tumour ends and healthy tissue begins.
The study involves a special dye called SGM-101. This dye has been designed to attach to a protein (carcinoembryonic antigen) often found on pancreatic cancer cells. When the dye is injected into the body, it makes the cancer cells glow under a special type of light that surgeons can see. This glowing effect is hoped to act like a 'roadmap' for the surgeon, highlighting the main tumour, any spread to nearby lymph nodes, and even tiny areas of cancer that might have spread further away, which wouldn't normally be visible to the naked eye. The main goal is to see if this glowing dye can help surgeons identify the full extent of the cancer more accurately, making it easier to remove as much of it as possible.
Researchers will also be looking at how well the dye's glow matches what they find when they examine the removed tissue closely under a microscope. They're also collecting blood and lymph fluid samples during surgery and follow-up to look for tiny particles that might be linked to cancer spreading. This information could help us understand more about pancreatic cancer and how it behaves.
Key takeaways
- This study uses a special dye to help surgeons see pancreatic cancer more clearly.
- It aims to improve how much of the cancer can be removed during an operation.
- The dye helps highlight the tumour and any spread that might otherwise be hard to spot.
- It's for people who have already received treatment before their pancreatic cancer surgery.
- Taking part helps advance our understanding and treatment of pancreatic cancer.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.
The study is specifically for people who are having surgery for pancreatic cancer and have already received some treatment for it, such as chemotherapy or radiotherapy, before the operation.
Other specific medical details and health conditions would be checked by the study doctors to make sure it's safe and suitable for you.
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 been diagnosed with pancreatic cancer?
- Are you scheduled for surgery for your pancreatic cancer?
- Have you already received chemotherapy or radiotherapy for your pancreatic cancer before this planned surgery?
What does participation involve?
If you decide to take part in this study, you would first have a screening visit to make sure you meet all the requirements. If eligible, you would receive an injection of the SGM-101 dye before your pancreatic cancer surgery. During your surgery, the surgical team would use a special camera system to look for areas that glow where the dye has attached to cancer cells.
Tissue samples removed during your surgery would be carefully checked to compare what the camera saw with what the pathologists find. You would also have some blood and possibly lymph fluid samples taken during your surgery for further analysis. After your surgery, there will be follow-up appointments to monitor your recovery and collect more information. The total duration of your participation would depend on the follow-up schedule determined by the study plan.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is SGM-101?
SGM-101 is a special dye designed to attach to pancreatic cancer cells and make them glow under a particular light, helping surgeons see them better during an operation.
Why is this study important?
This study is important because it aims to make it easier for surgeons to find and remove all pancreatic cancer, especially after other treatments, which could lead to better outcomes for patients.
Will this dye make me glow?
No, the SGM-101 dye only glows under a special camera system used during surgery, so you won't glow or look different afterwards.
Do I have to stop my usual cancer treatment to join?
No, this study is designed for people who have already had chemotherapy or radiotherapy before their surgery, so it works alongside your existing treatment plan.
What if I change my mind about taking part?
You are free to leave the study at any time, for any reason, and your decision will not affect the quality of 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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