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Study of SGM-101 Fluorescent Imaging for Detection of Early Rectal Cancer in Patients with Suspected T1 Adenocarcinoma or High-Grade Dysplasia

Fast replyInvestigationalNo placebo
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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 early rectal cancer, specifically examining suspicious growths in the rectum that may contain cancer cells or abnormal cell changes. The study uses a special medication called SGM-101, which is a fluorescent substance that can help doctors better see the difference between normal tissue and potentially cancerous areas during examination procedures.

The medication SGM-101 is given through an intravenous infusion (delivered directly into a vein). This substance is designed to attach to specific markers that are typically found on cancer cells, making them visible under special lighting during examination. The purpose of the study is to determine if this fluorescent imaging technique can effectively distinguish between normal tissue and areas with different levels of cell abnormalities in the rectum.

The study is conducted in two phases. The first phase aims to find the most effective dose of the medication. The second phase tests how well the fluorescent imaging technique works in identifying different types of tissue changes. During the procedure, doctors use a special camera system that can detect the fluorescent signals from the medication, allowing them to examine the suspicious areas in detail.

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 special medication that helps detect cancer tissue, through an intravenous infusion (delivery of medication through a vein)

    The medication is a solution that contains a substance that attaches to cancer cells and makes them visible under special light

  2. Step 2

    Waiting period

    After receiving the medication, there will be a waiting period to allow the substance to reach the targeted tissue

  3. Step 3

    Endoscopic examination

    A doctor will perform an endoscopic examination of your rectum using special equipment that can detect the fluorescent substance

    This examination helps distinguish between normal tissue and potentially cancerous areas

    The examination focuses on the area between 0 and 10 centimeters from the anal opening

  4. Step 4

    Tissue removal procedure

    During the examination, the doctor will remove the suspicious tissue in one piece (en-bloc resection)

    The removed tissue will be examined using special cameras and microscopes to evaluate the effectiveness of the fluorescent substance

  5. Step 5

    Laboratory analysis

    The removed tissue will undergo detailed laboratory examination to confirm the presence of cancer cells

    The results will help determine if all suspicious tissue has been successfully removed

Who can join the trial?

5 criteria

  • Patient must have suspected early rectal cancer (specifically T1RC/HGD) and be scheduled for a local endoscopic en-bloc resection (a procedure where the abnormal tissue is removed in one piece). The affected area must be in the rectum between the linea dentata (the boundary between the anal canal and rectum) and 10 centimeters above the anus
  • Must be over 18 years old
  • Must be able to understand and willing to sign an informed consent form before any study procedures begin
  • Both men and women can participate in this study
  • Must be mentally capable of making their own healthcare decisions (not considered a vulnerable population)

Who cannot join the trial?

14 criteria

  • Known allergies to fluorescent dyes or related compounds
  • Previous radiation therapy to the pelvic area (lower abdomen)
  • Pregnancy or breastfeeding
  • Active inflammatory bowel disease (conditions causing inflammation in digestive tract)
  • Previous major abdominal surgery within the last 6 months
  • Presence of other types of cancer that are currently active
  • Severe heart, kidney, or liver problems
  • Immunodeficiency (weakened immune system) conditions
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that may affect ability to provide informed consent
  • Use of medications that could interfere with fluorescent imaging
  • Metastatic disease (cancer that has spread to other parts of the body)
  • Inability to undergo required imaging procedures
  • History of adverse reactions to similar medical procedures
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Investigated drugs

SGM-101 is an investigational fluorescent tracer designed to help doctors better identify and distinguish between different types of tissue during endoscopic procedures in the rectum. When used with a special fluorescence-laparoscope (imaging device), this tracer binds to specific targets in cancerous or pre-cancerous tissue, making them glow and easier to detect compared to normal tissue. This helps doctors more accurately identify areas of concern during examination of rectal polyps. The imaging procedure uses the Quest Medical Imaging fluorescence-laparoscope, which is a specialized medical device that can detect and display the fluorescent signal from SGM-101 during the endoscopic examination.

What is already known about the treatment

SGM-101 - A tumor-targeted fluorescent tracer administered before endoscopic procedures to help visualize and distinguish between normal tissue and cancerous lesions in rectal cancer. This investigational compound is currently being studied in clinical trials for its ability to enhance detection of high-grade dysplasia and early rectal cancer during endoscopic examinations. The medication works by binding to specific markers present on cancer cells and emitting fluorescent signals when exposed to specialized imaging equipment, allowing surgeons to better identify cancerous tissue during procedures. SGM-101 belongs to the class of diagnostic imaging agents and is being evaluated in combination with CE-marked fluorescence-laparoscope technology from Quest Medical Imaging.

Investigated diseases

Early Rectal Cancer – A condition that develops in the rectum (the last part of the large intestine) when abnormal cells begin to grow and form tumors in the early stages. The disease starts in the innermost lining of the rectum and can gradually grow deeper into the rectal wall. Early rectal cancer typically begins as small growths called polyps, which can develop into cancer over time. The condition may progress from low-grade changes in the cells to more significant changes, potentially affecting deeper layers of the rectal tissue.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510769-41-00Protocol codeNL83765.058.23Estimated enrolment20 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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