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Study of SGM-101 fluorescent antibody to detect brain metastases from colorectal cancer during surgery

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What is this trial about?

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

This study focuses on patients with brain metastases that have spread from colorectal cancer. The research evaluates a new imaging method using SGM-101, which is a special solution for injection. This medication is a fluorescent antibody that attaches to specific markers found on cancer cells, making them visible during surgery.

The purpose of the study is to determine how well SGM-101 can help surgeons detect and locate brain metastases during surgery. The medication is given through intravenous infusion before the surgical procedure. During the operation, doctors use a special camera system called the Quest Spectrum System to see the areas where the fluorescent medication has attached to cancer cells.

The study treatment involves a single dose of up to 15 milligrams of SGM-101. After receiving the medication, patients will undergo their planned brain surgery while doctors use the fluorescent imaging system. The study will monitor patients' recovery and any side effects that may occur after the procedure.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication administration

    You will receive SGM-101, a specialized medication that helps detect brain metastases during surgery

    The medication will be given through an intravenous infusion (directly into your vein)

  2. Step 2

    Pre-surgery monitoring

    Medical staff will check your vital signs, including:

    - Blood pressure

    - Heart rate

    - Body temperature

    Your neurological status will be assessed using the Glasgow Coma Scale

  3. Step 3

    Surgical procedure

    Surgery will be performed to remove the brain metastases

    During the operation, SGM-101 will help doctors identify the affected tissue through fluorescence imaging

    The surgical team may adjust the operation plan based on what they see with the imaging

  4. Step 4

    Post-surgery monitoring

    Medical staff will continue monitoring your vital signs

    You will be checked for any unexpected symptoms, including:

    - Seizures

    - Changes in brain function

    Any medications you need will be documented

  5. Step 5

    Follow-up period

    You must continue using effective contraception for at least 30 days after receiving the study medication

    Your health status will be monitored for any delayed effects

    The study team will document any side effects that may occur

Who can join the trial?

5 criteria

  • Must sign an informed consent form before any study procedures begin
  • Must be over 18 years old
  • Must have a confirmed diagnosis of brain metastasis from colorectal cancer (cancer that has spread from the colon or rectum to the brain) and be scheduled for surgical removal
  • Must be able to communicate effectively with the study doctor in Dutch language and follow study requirements
  • For women who can become pregnant and all men: must use effective birth control during the study and continue for at least 30 days after the last study treatment

Who cannot join the trial?

15 criteria

  • Age under 18 years
  • Inability to provide informed consent
  • Pregnant or breastfeeding women
  • Known allergy to fluorescent dyes or similar substances
  • Active infection at the surgical site
  • Participation in another clinical trial within the past 30 days
  • History of severe allergic reactions to medications
  • Serious medical conditions that could interfere with surgery
  • Previous brain surgery in the area to be operated
  • Impaired kidney function (as this may affect how the body processes the study medication)
  • Use of medications that could interact with the study drug
  • Mental conditions that could affect the ability to follow study procedures
  • History of adverse reactions to surgical procedures
  • Unable to undergo MRI scanning (for example, due to metal implants)
  • Life expectancy less than 3 months
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Investigated drugs

SGM-101 is a specialized imaging agent that combines an antibody (targeting a specific protein called carcinoembryonic antigen) with a fluorescent dye. This medication is designed to help surgeons better see colorectal cancer that has spread to the brain during surgery. When given to patients before surgery, it attaches to cancer cells and makes them glow under special lighting, helping doctors to identify and remove cancer tissue more precisely.

What is already known about the treatment

SGM-101 - A fluorochrome-labeled monoclonal antibody specifically designed to target carcinoembryonic antigen (CEA) in colorectal cancer cells that have spread to the brain. This investigational agent is administered intravenously before surgery and helps surgeons identify cancer tissue during operations by making tumor cells fluorescent, which improves the precision of surgical removal of brain metastases. The medication belongs to the class of targeted fluorescent imaging agents and is currently being evaluated in clinical trials to determine its effectiveness in detecting and guiding the surgical removal of colorectal cancer metastases in the brain.

Investigated diseases

  • Brain Metastases

    A condition where cancer cells spread from their original site to the brain, forming new tumors. These secondary tumors develop when cancer cells break away from the primary tumor, travel through the bloodstream or lymphatic system, and establish themselves in brain tissue. Brain metastases commonly originate from cancers in other parts of the body, such as colorectal cancer, lung cancer, or breast cancer. The metastatic tumors can develop in any part of the brain and may be single or multiple. The growth of these tumors can affect normal brain function by putting pressure on or damaging surrounding brain tissue.

  • Colorectal Cancer

    A cancer that starts in the colon or rectum, parts of the large intestine. It typically begins as small, benign clumps of cells called polyps that form on the inner lining of the colon or rectum. Over time, some of these polyps can become cancerous and grow into the wall of the colon or rectum. The cancer cells can then spread to nearby tissues and, in some cases, travel to other parts of the body through the blood or lymphatic system.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510767-30-00Protocol codeNL74956.058.21Estimated enrolment10 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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