Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Focus Green: Fluorescence-guided resection Of Colorectal liver metastases Using SGM-101 and Indocyanine GREEN

This study, called 'Focus Green', is testing a new approach to help surgeons find and remove bowel cancer that has spread to the liver. It uses two special dyes, SGM-101 and Indocyanine Green (ICG), that glow under a special light during surgery. This glowing helps surgeons see where the cancer cells are, even tiny ones that might be hard to spot with the naked eye. The main goals are to see how practical this method is for surgeons, how patients feel about it, and how accurately SGM-101 can highlight cancer. The ultimate aim is to improve the chances of removing all cancerous tissue and, hopefully, lead to better outcomes for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Leiden University Medical Center

Enrolment target

Start

14 Aug 2023

colorectal livermetastases

What is this study about?

This study, called "Focus Green," is looking into a new technique to help doctors treat bowel cancer that has spread to the liver, known as colorectal liver metastases. When bowel cancer spreads, it often goes to the liver, and surgery to remove these growths is a common treatment. However, it can sometimes be difficult for surgeons to see all the cancer cells, especially very small ones or those on the surface of organs, during an operation.

This new technique uses special dyes that are given to the patient before or during surgery. These dyes, called SGM-101 and Indocyanine Green, are chosen because they behave differently in healthy tissue compared to cancer cells. When a special light is shone on them during surgery, these dyes make the cancer cells glow, or "fluoresce." This glow acts like a highlighter, helping the surgeon to clearly identify cancerous areas that might otherwise be missed. The study aims to find out how well this method works and if it helps surgeons remove more cancer.

We also want to understand the experiences of patients involved in this new type of surgery and how practical it is for the surgical team. By using these glowing dyes, the hope is to improve the accuracy of cancer removal, leading to more successful operations and better health outcomes for patients facing this challenging condition.

Key takeaways

This study uses special 'glowing' dyes to help surgeons find bowel cancer in the liver.
The goal is to improve how accurately cancer is removed during surgery.
It also checks how practical the new method is for surgeons and how patients feel about it.
Participation involves receiving the dyes and potentially completing surveys.
This is an early-stage (Phase II) study, testing a new technique.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also be included. Both men and women are welcome to take part in this research.

The study is specifically for people who have bowel cancer that has spread to their liver. However, it's important to remember that this is a broad overview. The research team will have a detailed list of other health requirements or previous treatments that might affect whether you can join. These details ensure that the study is safe and appropriate for everyone involved.

If you're interested, the doctors at the study site will carefully check your medical history to see if this study is a good fit for you. It's always best to have an open discussion with them to understand all the specific criteria.

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 bowel cancer that has spread to your liver?
Are you able to participate in surgery and follow-up appointments?
Are you willing to complete surveys about your experience?
Are you available to discuss your full medical history with the study team?

Answer every question to see your result.

What does participation involve?

The exact details of what taking part involves would be explained thoroughly by the study team, but generally, it would involve receiving the special dyes (SGM-101 and Indocyanine Green) before or during your surgery for colorectal liver metastases. During the operation, special imaging equipment would be used to see the glowing dyes. You would also be asked to complete some questionnaires: one about your experience as a patient and another for the surgical team about how practical the new method was during the operation. After your surgery, there would likely be follow-up appointments to monitor your recovery and the success of the treatment. The total duration would depend on your surgical and recovery journey, as well as the follow-up schedule determined by the study.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that it might help surgeons remove more of the cancer, improving the chances of a successful operation. However, as it's a new technique, there might be unforeseen risks or side effects from the dyes or imaging that are not yet fully understood. These would be explained in detail before you decide to take part. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What are 'colorectal liver metastases'?

This means bowel cancer that has spread to the liver. 'Metastases' is the medical word for when cancer spreads from its original location to another part of the body.

What are SGM-101 and Indocyanine Green?

These are special dyes. In this study, they are used to make cancer cells glow under a specific light during surgery, helping surgeons see them more clearly.

Will this technique change my surgery significantly?

The core of your surgery (removing the cancer) will remain the same, but this new technique adds the use of special dyes and imaging to help guide the surgeon. The study aims to understand how practical this is.

What does 'Phase II' mean for a study?

Phase II means this is an early-stage study focusing on whether a new treatment or method works well and is safe. It's usually after initial safety tests and involves a small number of patients.

How will my experience be measured?

You will be asked to complete a survey about your experience during and after the surgery, helping the researchers understand what it was like for you.