SGM-T1: SGM-101 tumor targeted fluorescence endoscopy in rectal polyps with suspected T1 adenocarcinoma or high grade dysplasia
Rectal polyps are small growths on the lining of the back passage. While many are harmless, some can develop early cancer or severe precancerous changes. During standard camera examinations, it can be difficult for doctors to see where healthy tissue ends and early cancer begins. This Phase II clinical trial is testing a new marker dye called SGM-101. People having a rectal polyp removed receive the dye through a simple vein drip. SGM-101 attaches to a protein commonly found on cancer cells and glows brightly under a special near-infrared camera. Doctors are testing whether this glow helps them detect early cancer inside polyps and check that all abnormal tissue has been safely taken out. By making early cancer easier to see during procedures and in the laboratory, this technique aims to make treatments more precise and help some patients avoid larger bowel operations.
At a glance
What is this study about?
Polyps are small, fleshy growths that can form on the lining of the rectum, which is the final section of the large bowel. Most polyps are harmless, but over time, some develop abnormal changes known as high-grade dysplasia or early bowel cancer. When doctors find these growths, they aim to remove them early and completely to stop cancer from growing or spreading.
At present, it can be tricky for doctors to tell harmless tissue apart from early cancer just by looking through a standard camera. This study investigates a medical dye called SGM-101. The dye is designed to seek out and stick to a specific protein found on bowel cancer cells. When doctors shine a safe, invisible near-infrared light on the area, the dye glows. A special camera picks up this glow, creating a clear map of any dangerous cells.
Researchers are using this glowing dye both during the procedure to remove the polyp and afterwards when examining the tissue under a microscope. They want to confirm whether the dye reliably highlights early cancer cells and shows clear boundaries around them.
If successful, this technique could help surgeons remove polyps with greater precision. Ensuring every bit of abnormal tissue is removed the first time could spare patients from needing more invasive bowel operations or repeat procedures in the future.
Key takeaways
- Tests a glowing dye (SGM-101) to help doctors spot early cancer in rectal polyps.
- The dye lights up under special near-infrared cameras to show exact edges of abnormal cells.
- Aimed at adults having a suspected early-stage rectal cancer polyp removed.
- Designed to improve the precision of removal and laboratory tissue checks.
- Participation is voluntary and takes place alongside your planned hospital treatment.
Who may be eligible?
This trial is designed for adults aged 18 and over who have been diagnosed with a rectal polyp that doctors suspect might contain early cancer or severe precancerous cell changes.
To be considered, you must already be scheduled to have your polyp removed through an endoscopy (a camera test) or a minor procedure through the back passage. The study is open to both men and women.
You may not be able to join if you have known allergies to the dye ingredients, if you are pregnant, or if you have other serious medical conditions that mean the procedure would not be safe for you. Your hospital doctor will review your test results and general health to see if this trial is 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.
- I am aged 18 or older.
- I have been told I have a polyp in my rectum (back passage).
- My medical team suspects the polyp may contain early cancer or severe cell changes.
- I am already due to have the polyp removed.
- I am willing and able to receive a medicine through a vein drip.
What does participation involve?
If you take part, you will receive your planned care with a few added steps. Before your polyp removal, you will be given the SGM-101 dye through a small needle into a vein (a drip). During your planned procedure, your doctor will use a camera equipped with near-infrared light to see if any areas glow.
After your polyp is removed, laboratory specialists will also look at the tissue using special light scanners to see how accurately the dye highlighted any abnormal cells. You will be monitored closely by the research team for any side effects from the dye. You may have a short follow-up visit or phone call to check on your recovery, which fits into your usual post-procedure schedule.
Potential risks and benefits
Locations (1)
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Common questions
What is SGM-101?
It is an investigational dye that attaches to a protein found on cancer cells, making them glow under a special camera.
Will I glow in the dark after getting the dye?
No. The dye only lights up under a specific type of invisible near-infrared light used by the medical team's camera.
Does this replace my normal polyp removal?
No. You will still have your planned procedure to remove the polyp. The dye is an added tool to help doctors see the cells clearly.
How is the dye given?
The dye is given through a standard intravenous drip into a vein in your arm, similar to having a routine blood test or fluid drip.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time without giving a reason, and your normal healthcare will continue as usual.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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