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Study on Fluorescence-Guided Surgery for Colorectal Liver Metastases Using SGM-101 and Indocyanine Green for Patients with Colorectal Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as colorectal liver metastases, which occurs when cancer cells from the colon or rectum spread to the liver. The study is exploring a new approach to help surgeons see these cancerous areas more clearly during surgery. This involves using a special treatment called SGM-101, which is a type of protein designed to attach to cancer cells and make them glow under a special light. This glow helps doctors identify and remove the cancer more effectively. The study also uses a substance called Indocyanine Green, which is another type of dye that helps highlight the cancerous areas.

The purpose of the study is to see if using both SGM-101 and Indocyanine Green together can improve the way doctors find and remove liver metastases from colorectal cancer during surgery. Participants in the study will receive these substances through an injection before their surgery. During the operation, the surgeons will use special imaging techniques to see how well these substances highlight the cancerous areas. This will help them decide the best way to remove the cancer.

The study will follow participants through their surgical procedure and assess how well the substances work in highlighting the cancer. The goal is to determine if this method can make surgeries more successful by ensuring that all cancerous tissue is removed. This could potentially lead to better outcomes for patients with colorectal liver metastases. The study will also gather feedback from both the surgeons and the patients to understand their experiences with this new approach.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose and procedures. You will be asked to provide informed consent, confirming your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have been diagnosed with colorectal liver metastases and meet specific criteria, such as being scheduled for surgical resection or having completed recent therapy.

  3. Step 3

    Pre-surgery preparation

    Before surgery, you will receive an intravenous injection of SGM-101, a solution designed to help visualize the cancerous tissue during surgery. The dosage and timing will be determined by the medical team.

  4. Step 4

    Surgery

    During the surgery, the medical team will use special imaging techniques to identify and remove the cancerous tissue. The use of SGM-101 and Indocyanine Green will assist in this process by highlighting the affected areas.

  5. Step 5

    Post-surgery evaluation

    After the surgery, you will undergo evaluations to assess the success of the procedure. This includes checking for any remaining cancerous tissue and ensuring there is no interference between the imaging agents used.

  6. Step 6

    Follow-up and feedback

    You will be asked to provide feedback on your experience through a survey. This feedback is important for assessing the practical aspects of the trial and your personal experience.

Who can join the trial?

6 criteria

  • Diagnosed with liver metastases of colorectal origin (cancer that started in the colon or rectum and spread to the liver) for which surgery is planned.
  • Meet at least one of the following conditions:
    • Scheduled for surgery to remove more than 3 colorectal liver metastases.
    • Completed treatment before surgery, with the last treatment finished within 3 months before the surgery.
    • Scheduled for surgery due to a liver metastasis that has come back in the same area.
    • At least 18 years old.
    • Willing and able to give informed consent (permission to participate after understanding the study) before any study-specific procedures.

Who cannot join the trial?

8 criteria

  • Patients with **colorectal liver metastases** cannot participate if they have any other serious medical conditions that might interfere with the study.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are pregnant or breastfeeding are not eligible to participate in the study.
  • Patients who have participated in another clinical trial recently may not be eligible to join this study.
  • Patients with known allergies to the substances used in the study, such as **ICG** (a dye used for imaging) or **SGM-101** (a substance used for imaging), cannot participate.
  • Patients who are unable to provide informed consent, meaning they cannot understand the study and agree to participate, are not eligible.
  • Patients with a history of severe allergic reactions to medications or substances similar to those used in the study cannot participate.
  • Patients with certain medical conditions that might affect the study results or their safety during the study cannot participate.
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Investigated drugs

  • SGM-101

    is a special type of medication used in this trial to help doctors see cancerous areas more clearly during surgery. It works by attaching to cancer cells and lighting them up, making it easier for surgeons to find and remove tumors in the liver that have spread from the colon.

  • Indocyanine Green

    is another medication used in this trial to help with imaging during surgery. It is a dye that, when injected into the body, helps highlight blood vessels and tissues. This makes it easier for doctors to see the areas they need to operate on, ensuring they can remove as much of the cancer as possible while avoiding healthy tissue.

What is already known about the treatment

  • SGM-101

    SGM-101 is administered as an injection and is used during surgery to help doctors see cancerous tissues more clearly. It is currently being studied in clinical trials for its effectiveness in identifying colorectal liver metastases. The main use of SGM-101 is to assist surgeons in removing cancerous tissues by making them glow under special lighting. It works by binding to cancer cells and emitting a fluorescent signal, which helps differentiate cancerous tissue from healthy tissue. SGM-101 is classified as a diagnostic imaging agent.

  • Indocyanine Green (ICG)

    Indocyanine Green is given as an injection and is used in medical imaging to help visualize blood flow and tissue structures during surgery. It is a well-established substance in medical practice and literature, often used in various types of surgeries, including those involving the liver. The primary use of ICG is to enhance the visibility of tissues and blood vessels, aiding in the precise removal of tumors. It works by absorbing light and emitting fluorescence, which can be detected with special cameras. Indocyanine Green is classified as a diagnostic imaging agent.

Investigated diseases

Colorectal Liver Metastases – Colorectal liver metastases occur when cancer cells from the colon or rectum spread to the liver. This process begins when cancerous cells break away from the primary tumor in the colon or rectum and travel through the bloodstream to the liver. Once in the liver, these cells can form new tumors. The progression of the disease involves the growth and multiplication of these metastatic tumors within the liver tissue. Over time, these tumors can affect liver function and may lead to further complications. The disease is a common occurrence in advanced colorectal cancer cases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504615-33-00Estimated enrolment10 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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