RecruitingNAINTERVENTIONAL

Lymph Node Mapping Via Flourescent Dye in Colon Cancer

Doctors are trying to understand how colon cancer might spread. This study focuses on tiny glands called lymph nodes, which are part of your body's immune system. When cancer spreads, it often travels to these nodes first. Currently, surgeons remove lymph nodes from a specific area during an operation. This study wants to see if lymph nodes that drain cancer from the bowel are always in these standard areas, or if some are found in unexpected places. To do this, a special non-toxic dye is injected near the tumour before surgery. During the operation, a special camera helps doctors see which lymph nodes have taken up the dye. This helps them track where cancer might spread and could lead to more effective surgery.

At a glance

Status

Recruiting

Phase

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Enrolment target

Start

31 May 2021

Estimated completion

30 Dec 2026

Colon Carcinoma Lymph Node Metastases

What is this study about?

This study is designed to help us better understand how colon cancer cells might spread within the body. When someone has colon cancer, surgeons usually remove the part of the bowel with the tumour and also some nearby lymph nodes. Lymph nodes are small, bean-shaped glands that are part of your immune system. Cancer cells often travel to these nodes first if they start to spread from the original tumour.

The main goal of this research is to see if the lymph nodes that are connected to the area around the cancer are always found in the places doctors usually check, or if they can sometimes be located a bit further out. Knowing this could be very important because it might mean surgeons need to look in slightly different or wider areas to make sure all potentially affected nodes are removed during surgery. This could ultimately help improve how colon cancer is treated.

To figure this out, a special, safe dye called indocyanine green (ICG) is used. It's injected near the tumour in the colon a few days before surgery. During the operation, doctors will use a special camera that can see this dye. This allows them to clearly spot which lymph nodes have taken up the dye, showing them where the cancer's drainage pathways lead. They will then remove these nodes, along with the standard ones, and examine them closely. By comparing where these dye-stained nodes are found and whether they contain cancer cells, researchers hope to get a clearer picture of how colon cancer spreads.

Key takeaways

The study aims to improve understanding of how colon cancer spreads to lymph nodes.
A special dye (ICG) is used to map lymph nodes near the cancer before surgery.
Doctors will use a camera during surgery to find these dye-stained lymph nodes.
The research helps determine if cancer-affected nodes are always in expected locations.
Improved understanding could lead to more effective surgical removal of cancer.

Who may be eligible?

To join this study, people need to have been diagnosed with colon cancer. This includes cancer in specific parts of the colon, such as the ascending, transverse, descending, or sigmoid colon. The diagnosis must have been confirmed by a medical test.

There are a few reasons why someone might not be able to join. For example, if you have a different type of cancer than the one we're studying, or if it's not possible for the doctors to inject the special dye near your tumour using a tiny camera (endoscope), you wouldn't be able to take part. Also, if you simply don't want to participate, that's perfectly fine, and you wouldn't be included.

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.

Do I have a confirmed diagnosis of colon cancer in the ascending, transverse, descending, or sigmoid colon?
Am I willing to participate in a research study?
Is it possible for doctors to use an endoscope to inject dye near my tumour?
Am I at least 18 years old?
Am I not diagnosed with a type of cancer different from colon cancer (adenocarcinoma)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first need to have a confirmed diagnosis of colon cancer. A few days before your planned surgery (between one and five days), a doctor would use a thin, flexible tube with a camera on the end (an endoscope) to inject a special dye called indocyanine green (ICG) at four points around your tumour. This is a standard procedure and the dye is considered safe.

During your surgery, the surgical team will use a special camera to identify any lymph nodes that glow because they've absorbed the dye. They will carefully record and photograph the exact location of all these glowing nodes. After removing the part of your colon with the tumour and the standard lymph nodes, they will also remove any glowing nodes found outside the usual area. All these removed tissues and nodes will then be sent to a lab for detailed examination. The study essentially adds an extra step to your pre-surgical preparation and a visual check during your existing surgery; it does not require additional visits or follow-up beyond your standard care.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping doctors understand more about how colon cancer spreads, which could lead to better treatments in the future. For you personally, it won't directly change your treatment plan, but it could help your doctors ensure all necessary lymph nodes are identified during your surgery. The main risks are associated with the minor procedure of injecting the dye, though this dye is generally very safe and widely used. As with any medical study, you have the right to withdraw at any time without giving a reason, and your decision will not affect the quality of your medical care.

Locations (1)

University of Hamburg Medical Institutions
Verified postcode
Hamburg, Germany· Recruiting

Common questions

What are lymph nodes?

Lymph nodes are tiny, bean-shaped glands that are part of your body's immune system, helping to fight off infections and diseases like cancer.

What is the special dye used in this study?

The dye is called indocyanine green (ICG). It's a safe, non-toxic substance that glows under a special camera, helping doctors see specific lymph nodes.

Will taking part in this study change my surgery?

The study adds a step before and during your surgery to help identify lymph nodes. Your main surgery for colon cancer will proceed as planned.

Is the dye safe?

Yes, indocyanine green (ICG) dye is commonly used in medical procedures and is considered safe for most people.

Why is this research important?

It could help doctors get a clearer picture of how colon cancer spreads, potentially leading to more thorough surgery and better outcomes for future patients.

How to find out more

Katharina L Lucas, MD

katharina.lucas@uni-wh.de +4915779600815 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.