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This article discusses a clinical trial investigating the use of EMI-137, a novel fluorescent tracer, for intraoperative visualization in patients with penile and tongue cancer. The study aims to assess the feasibility of using this c-Met-based receptor-mediated fluorescence imaging technique to improve tumor detection and visualization during surgery. The trial also explores the potential of EMI-137 in identifying lymph node metastases and detecting dysplasia or carcinoma in situ in these types of cancers.

Table of Contents

What is EMI-137?

EMI-137, also known as GE-137, is a new medication being studied for its potential to help doctors better visualize cancer during surgery[1]. It’s classified as a fluorescent tracer, which means it’s a substance that can make certain parts of the body “light up” when viewed with special equipment. This medication is currently in a Phase II clinical trial, which is an important step in determining if it’s safe and effective for wider use[1].

How Does EMI-137 Work?

EMI-137 is a unique combination of two parts[1]:

  1. A peptide (a small protein-like molecule) that targets a specific receptor called c-Met, which is often found in higher amounts on cancer cells.
  2. A fluorescent dye called Cy5.
When injected into the body, EMI-137 seeks out cancer cells and attaches to them. Then, when doctors use special imaging equipment during surgery, the areas with cancer “light up,” making them easier to see and potentially remove[1].

Medical Conditions Targeted

The current clinical trial is focusing on two types of cancer[1]:

  • Penile carcinoma: This is a rare type of cancer that affects the skin and tissues of the penis.
  • Tongue carcinoma: This is a type of oral cancer that specifically affects the tongue.
Both of these cancers are classified as squamous cell carcinomas, which means they start in the flat cells that line certain parts of the body[1].

Clinical Trial Objectives

The main goal of this clinical trial is to see if EMI-137 can effectively help surgeons visualize cancer during operations[1]. Specifically, researchers want to know:

  • If EMI-137 can help detect and visualize lymph node metastases (cancer that has spread to the lymph nodes) in patients with penile and tongue tumors.
  • If it can identify areas of dysplasia (abnormal cell growth) or carcinoma in situ (very early-stage cancer) in these types of tumors.
  • How safe EMI-137 is to use, by monitoring for any side effects.

Eligibility Criteria

To participate in this clinical trial, patients must meet certain criteria[1]:

  • Be at least 18 years old
  • Have penile or tongue squamous cell cancer that is classified as T1 or higher (meaning the tumor has grown to a certain size or depth)
  • Be scheduled for surgical removal of their primary tumor
  • Provide written informed consent
Some factors that would prevent a person from participating include:
  • Severe kidney problems
  • Pregnancy or plans to become pregnant within 90 days of the study
  • Being involved in the planning or conduct of the study

Potential Benefits

If successful, EMI-137 could provide several benefits for cancer patients and surgeons[1]:

  • More accurate tumor removal: By making cancer cells “light up,” surgeons might be able to remove tumors more completely.
  • Better detection of spread: It could help find cancer that has spread to nearby lymph nodes, which is crucial for proper treatment and staging.
  • Earlier detection: It might help identify very early-stage cancers or pre-cancerous changes that are hard to see with the naked eye.

Administration and Dosage

EMI-137 comes as a powder that is mixed into a solution for injection. It is given through an intravenous bolus injection (a quick injection into a vein) or an IV infusion (a slow drip into a vein)[1]. The maximum dose being tested is 0.13 mg per kilogram of body weight, and it’s typically given just once before surgery[1].

Aspect Details
Study Title INtra-operative evaluation of a novel FLUorescENt C-mEt tracer in penile and tongue cancer – INFLUENCE
Trial Category Phase II clinical trial
Medical Conditions Penile carcinoma and tongue carcinoma
Main Objective Assess feasibility of intraoperative visualization of primary penile and tongue tumors using EMI-137
Secondary Objectives 1. Detect and visualize lymph node metastases
2. Identify dysplasia or carcinoma in situ
3. Evaluate toxicity using CTCAE-NCI V4
Drug Information EMI-137 (Powder for injection, administered intravenously)
Dosage Maximum daily dose: 0.13 mg/kg
Maximum total dose: 0.13 mg/kg
Maximum treatment period: 1 day
Key Eligibility Criteria 1. Age ≥ 18 years
2. ≥ T1 penile or tongue squamous cell cancer
3. Scheduled for surgical primary tumor resection

FAQ

  • What is EMI-137 and how does it work? EMI-137 is a novel fluorescent tracer that targets the c-Met receptor. It is a peptide linked to a dye (Cy5) that helps visualize cancer cells during surgery. When injected into the patient, it binds to c-Met receptors, which are often overexpressed in cancer cells, making them visible under special lighting conditions during surgery.
  • What types of cancer does this clinical trial focus on? This clinical trial focuses on penile carcinoma and tongue carcinoma, which are both types of squamous cell cancers.
  • What is the main objective of the study? The main objective of the study is to evaluate the feasibility of using EMI-137 for intraoperative visualization of primary penile and tongue tumors using c-Met-based receptor-mediated fluorescence imaging.
  • What are some of the secondary objectives of the trial? Secondary objectives include detecting and visualizing lymph node metastases, identifying dysplasia or carcinoma in situ in penile and tongue tumors, and assessing the toxicity of EMI-137 using standardized criteria (CTCAE-NCI V4).
  • Who is eligible to participate in this clinical trial? Eligible participants must be 18 years or older, have T1 or higher stage penile or tongue squamous cell cancer, and be scheduled for surgical primary tumor resection. They must provide written informed consent and meet other specific criteria. Patients with severe kidney insufficiency or those involved in the planning and conduct of the study are not eligible.

Ongoing Clinical Trials on Ac-Ala-Gly-Ser-Cys(1)-Tyr-Cys(2)-Ser-Gly-Pro-Pro-Arg-Phe-Glu-Cys(2)-Trp-Cys(1)-Tyr-Glu-Thr-Glu-Gly-Thr-Gly-Gly-Gly-Lys(Unk)-Nh2 Conjugated To Cy5 Dye

  • Study on Using EMI-137 for Intraoperative Visualization in Patients with Penile and Tongue Cancer

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

Glossary

  • EMI-137: A novel fluorescent tracer used in this study, consisting of a peptide linked to a Cy5 dye. It targets the c-Met receptor to help visualize cancer cells during surgery.
  • c-Met receptor: A protein found on the surface of cells that is often overexpressed in cancer cells. EMI-137 targets this receptor to make cancer cells visible during surgery.
  • Intraoperative visualization: The ability to see and identify specific tissues or cells during a surgical procedure.
  • Fluorescence imaging: A technique that uses special dyes or tracers that emit light when exposed to certain wavelengths, allowing surgeons to see specific tissues or cells more clearly during surgery.
  • Squamous cell cancer: A type of skin cancer that develops in the squamous cells, which are flat cells found in the outer layer of the skin and in the lining of some organs.
  • Carcinoma in situ: An early stage of cancer where abnormal cells are found only in the layer of cells where they began and have not spread to other tissues.
  • Dysplasia: Abnormal cell growth or development in a tissue or organ, which may be a precursor to cancer.
  • Lymph node metastases: The spread of cancer cells from the original tumor to the lymph nodes.
  • CTCAE-NCI V4: Common Terminology Criteria for Adverse Events, version 4, developed by the National Cancer Institute. It is a set of criteria used to evaluate the safety and toxicity of treatments in cancer clinical trials.

References

  1. http://clinicaltrials.eu/trial/study-on-using-emi-137-for-intraoperative-visualization-in-patients-with-penile-and-tongue-cancer/