SGM-CBM: A feasibility study of SGM-101, a fluorochrome-labeled anti-carcinoembryonic antigen monoclonal antibody for the intraoperative detection of colorectal brain metastases.
Bowel cancer can sometimes spread to other areas of the body, including the brain. These secondary tumours are called brain metastases. When surgeons operate to remove them, it can be difficult to tell healthy brain tissue apart from cancer cells. This early-stage study is looking at a new medicine called SGM-101. It is an antibody linked to a harmless fluorescent dye that sticks to a protein found on bowel cancer cells. During surgery, a special camera shines light on the area to make the tumour glow. Researchers want to see if SGM-101 helps surgeons spot and remove cancer cells more accurately. They will compare what lights up during surgery with laboratory tests on the removed tissue. The study also closely tracks patient safety to see if using this dye causes any unexpected side effects.
At a glance
What is this study about?
When bowel cancer spreads to the brain, surgery is often needed to remove the tumours. However, brain tissue is delicate and complex. Surgeons must remove as much of the tumour as possible while protecting the healthy brain tissue that controls speech, movement, and thinking. Telling the edge of a tumour apart from healthy brain can be challenging with the naked eye.
This trial is testing an experimental dye called SGM-101. It works using a 'targeted antibody'—a protein designed to search for and attach itself to bowel cancer cells. Attached to this antibody is a special glowing marker. Before surgery, patients receive an injection of SGM-101. In the operating room, the surgeon uses a special near-infrared camera that causes the dye to light up, showing precisely where the tumour is.
The main goal of this study is to see how accurate the glowing dye is. After the operation, specialists in the laboratory will check the removed tissue to see if the areas that glowed were truly cancer. Doctors will also check whether the glowing dye helped them make better decisions during the operation, such as removing small bits of cancer that might have otherwise been missed.
Key takeaways
- Tests a glowing dye (SGM-101) to help surgeons see brain metastases from bowel cancer.
- Aims to check if the glowing areas accurately match cancer cells under the microscope.
- Open to adults aged 18 and older who are already planning surgery for this condition.
- Does not replace standard surgery, but adds a visual tool to guide the surgeon.
- Participation is entirely voluntary and you can leave the study at any time.
Who may be eligible?
This study is for adults aged 18 and over who have been diagnosed with bowel cancer that has spread to the brain (known as brain metastases) and who are already scheduled to have brain surgery to remove the tumour.
Both men and women may be eligible. Because the dye is designed specifically to attach to a protein made by bowel cancer, people with brain tumours that started in other parts of the body cannot take part.
Your surgical team and study doctors will carry out detailed health checks, including scans and blood tests, to make sure taking part and having surgery is safe for you. They will explain all other medical conditions that might prevent you from joining.
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 bowel (colorectal) cancer that has spread to my brain.
- My medical team has recommended brain surgery to remove the tumour.
- I am willing to receive an extra medicine (a dye) via a drip before surgery.
- I am able to attend all planned follow-up checks and monitoring visits.
What does participation involve?
If you take part, you will receive an infusion (a slow drip into a vein) of SGM-101 before your planned brain surgery. Your care team will monitor your blood pressure, heart rate, and temperature, and check for any unexpected symptoms such as seizures or changes in your neurological function.
During your scheduled operation, the surgeon will use a special camera to view the tumour and guide the surgery. Any tissue removed will be sent to the laboratory for detailed analysis. After your surgery, doctors will continue to check on your recovery, monitor your vital signs, and track any medications you take. Your doctor will explain the exact schedule of visits and follow-up checks before you decide to take part.
Potential risks and benefits
Locations (1)
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Common questions
What does SGM-101 do?
It is a medicine that travels through your bloodstream, attaches to bowel cancer cells, and glows under a special light to help the surgeon see the tumour.
Will taking part change my surgery date?
Usually, the study is planned around your standard surgery schedule, but your team will confirm exact timings with you.
Is the dye radioactive?
No. SGM-101 uses a fluorescent dye that lights up under near-infrared light, not radiation.
What happens if I decide not to take part?
You will receive standard surgical treatment and care from your medical team. Your decision will not affect the quality of your care.
Do I have to pay to be in the study?
No, clinical trials in the UK do not charge you for the study drug or extra study tests.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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