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Chimeric Monoclonal Antibody Against Carcinoembryonic Antigen Conjugated To Fluorochrome Bm-104

This article summarizes several clinical trials investigating the use of SGM-101, a fluorochrome-labeled antibody, for fluorescence-guided cancer surgery. SGM-101 targets carcinoembryonic antigen (CEA), which is expressed by many cancers. When injected before surgery, SGM-101 accumulates in tumor tissue and emits near-infrared fluorescence, helping surgeons visualize and remove cancerous tissue more precisely. The trials are evaluating SGM-101 for colorectal liver metastases, pancreatic cancer, brain metastases from colorectal cancer, locally advanced rectal cancer, and early rectal cancer.

Table of Contents

What is SGM-101?

SGM-101 is an innovative medical imaging agent being studied for use in cancer detection and surgery. It is classified as a chimeric monoclonal antibody that targets a protein called carcinoembryonic antigen (CEA), which is found in high levels in certain types of cancer cells[1]. The antibody is attached to a fluorescent dye that glows when exposed to near-infrared light, allowing surgeons to visualize cancer cells during operations.

How does SGM-101 work?

SGM-101 works through a process called fluorescence-guided surgery. Here’s how it functions:

  1. The drug is injected into the patient’s bloodstream before surgery.
  2. It circulates through the body and attaches to cancer cells that express CEA.
  3. During surgery, doctors use a special camera that can detect near-infrared light.
  4. When this light is shined on the surgical area, any cancer cells with SGM-101 attached will glow, making them visible to the surgeon.

This allows surgeons to more accurately identify and remove cancerous tissue, potentially improving the success of cancer surgeries[2].

What types of cancer can SGM-101 detect?

Based on current research, SGM-101 is being studied for use in several types of cancer, including:

  • Colorectal cancer, including liver metastases from colorectal cancer[1]
  • Pancreatic cancer[3]
  • Brain metastases from colorectal cancer[4]
  • Early rectal cancer[5]

These cancers often express high levels of CEA, making them good targets for SGM-101 imaging.

How is SGM-101 used during surgery?

SGM-101 is typically administered to patients via intravenous injection or infusion before surgery. The timing can vary, but it’s usually given 1-4 days before the operation. During surgery, doctors use a special camera system called the Quest Spectrum System to detect the fluorescent signal from SGM-101[2].

The fluorescent imaging helps surgeons in several ways:

  • Identifying the primary tumor and its borders
  • Detecting small metastases that might not be visible to the naked eye
  • Assessing whether all cancerous tissue has been removed
  • Guiding decisions about how much tissue to remove

What are the potential benefits of using SGM-101?

The use of SGM-101 in cancer surgery could potentially offer several benefits:

  • Improved tumor detection: It may help surgeons find small tumors or metastases that might be missed with conventional techniques.
  • More complete tumor removal: By clearly highlighting cancer cells, it could help ensure that all cancerous tissue is removed during surgery.
  • Reduced removal of healthy tissue: The precise imaging could help surgeons avoid removing unnecessary amounts of healthy tissue.
  • Better surgical outcomes: These factors combined could potentially lead to more successful surgeries and better outcomes for patients.

What are the side effects and risks?

As SGM-101 is still in clinical trials, the full range of potential side effects is not yet known. However, some possible risks include:

  • Allergic reactions: As with any drug, some people may be allergic to SGM-101. Patients with a history of severe allergic reactions are typically excluded from trials[3].
  • False positives: There’s a possibility that SGM-101 could sometimes highlight non-cancerous tissue, potentially leading to unnecessary removal of healthy tissue.
  • False negatives: Conversely, not all cancer cells may be detected, which could result in some cancerous tissue being left behind.

It’s important to note that SGM-101 is still being studied, and researchers are carefully monitoring for any potential side effects or risks.

Current research and clinical trials

Several clinical trials are currently underway to study the effectiveness and safety of SGM-101 in different cancer types:

  • A study on fluorescence-guided surgery for colorectal liver metastases[1]
  • A trial investigating SGM-101 for imaging pancreatic cancer during surgery[3]
  • Research on using SGM-101 to detect brain metastases from colorectal cancer[4]
  • A study on SGM-101 for detecting early rectal cancer[5]

These trials are assessing various aspects of SGM-101’s performance, including its ability to accurately detect cancer cells, its impact on surgical decision-making, and its safety profile.

While SGM-101 shows promise, it’s important to remember that it’s still an experimental drug. More research is needed to fully understand its benefits and risks before it can be approved for widespread use. Patients interested in SGM-101 should discuss current clinical trial opportunities with their healthcare providers.

Trial Name Cancer Type Main Objective Key Endpoints
Focus Green Colorectal liver metastases Assess feasibility of using SGM-101 with ICG for intraoperative imaging Practical workability, patient experience, sensitivity ≥80%
FLUOPANC II Pancreatic cancer Evaluate SGM-101 for visualizing tumor extent and resectability Tumor-to-background ratio ≥1.5, concordance with pathology
SGM-CBM Brain metastases from colorectal cancer Assess performance of SGM-101 in detecting brain metastases Concordance between fluorescent signal and tumor status
SGM-LARRC Locally advanced or recurrent rectal cancer Evaluate clinical benefit of fluorescence-guided surgery with SGM-101 Rate of R0 resections, changes in surgical planning
SGM-T1 Early rectal cancer Investigate feasibility of SGM-101 for discriminating normal, low-grade, and malignant tissue Ex-vivo fluorescence tumor-to-dysplasia ratio, accuracy in distinguishing tissue types

FAQ

  • What is SGM-101? SGM-101 is a fluorochrome-labeled antibody that targets carcinoembryonic antigen (CEA), a protein expressed by many cancers. It is injected before surgery and accumulates in tumor tissue, emitting near-infrared fluorescence to help surgeons visualize cancerous areas during operations.
  • What types of cancer are being studied with SGM-101? The clinical trials are evaluating SGM-101 for colorectal liver metastases, pancreatic cancer, brain metastases from colorectal cancer, locally advanced rectal cancer, and early rectal cancer.
  • How does SGM-101 work during surgery? When injected before surgery, SGM-101 accumulates in tumor tissue. During the operation, special cameras can detect the near-infrared fluorescence emitted by SGM-101, helping surgeons distinguish cancerous tissue from healthy tissue more accurately.
  • What are the main goals of these clinical trials? The main goals are to assess the safety and effectiveness of SGM-101 for fluorescence-guided cancer surgery. Researchers are evaluating how well SGM-101 helps surgeons visualize and remove cancerous tissue, potentially improving surgical outcomes and patient survival.
  • Are there any risks associated with using SGM-101? As with any investigational drug, there may be risks. The trials are monitoring for potential side effects, including allergic reactions. Patients with a history of severe allergic reactions are typically excluded from participating. Always consult with your doctor about potential risks and benefits of clinical trials.

Ongoing Clinical Trials on Chimeric Monoclonal Antibody Against Carcinoembryonic Antigen Conjugated To Fluorochrome Bm-104

  • Evaluating SGM-101 (fluorochrome-labeled antibody) in patients with locally advanced or recurrent rectal cancer undergoing surgery

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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

    Recruiting

    2 1 1
    Investigated drugs:
    The Netherlands

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

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study of SGM-101 fluorescent imaging agent to guide surgery in patients with pancreatic cancer who received prior treatment

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

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

    Not recruiting

    2 1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Carcinoembryonic antigen (CEA): A protein found in many types of cells, but particularly in cancer cells. High levels of CEA can be a sign of certain cancers.
  • Fluorescence-guided surgery: A surgical technique that uses fluorescent markers to highlight tumor tissue, helping surgeons distinguish between cancerous and healthy tissue during an operation.
  • Near-infrared fluorescence: A type of light not visible to the human eye, but detectable with special cameras. In these trials, SGM-101 emits near-infrared fluorescence when it accumulates in tumor tissue.
  • Tumor-to-background ratio (TBR): A measure of how well a fluorescent marker distinguishes tumor tissue from surrounding healthy tissue. A higher TBR indicates better visibility of the tumor.
  • R0 resection: A surgical outcome where all detectable cancer has been removed, with no cancer cells seen at the edges of the removed tissue under a microscope.
  • Metastases: Cancer that has spread from its original site to other parts of the body, such as liver or brain metastases from colorectal cancer.
  • Neoadjuvant treatment: Treatment given before the main treatment, usually to shrink a tumor before surgery.
  • Histopathology: The examination of tissue under a microscope to study the manifestations of disease.
  • Immunohistochemistry: A method of detecting specific proteins in tissues, used in these trials to measure CEA expression in tumor samples.

References

  1. http://clinicaltrials.eu/trial/study-on-fluorescence-guided-surgery-for-colorectal-liver-metastases-using-sgm-101-and-indocyanine-green-for-patients-with-colorectal-cancer/
  2. http://clinicaltrials.eu/trial/study-on-sgm-101-for-patients-with-locally-advanced-or-recurrent-rectal-cancer-undergoing-surgery/
  3. http://clinicaltrials.eu/trial/study-on-sgm-101-for-imaging-pancreatic-cancer-in-patients-undergoing-surgery-after-neoadjuvant-treatment/
  4. http://clinicaltrials.eu/trial/study-on-sgm-101-for-detecting-brain-metastases-in-colorectal-cancer-patients/
  5. http://clinicaltrials.eu/trial/study-on-sgm-101-for-detecting-early-rectal-cancer-in-patients-with-suspected-t1-adenocarcinoma-or-high-grade-dysplasia/