In short
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.
At a glance
- 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
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. 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.
How Does EMI-137 Work?
EMI-137 is a unique combination of two parts: 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. 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.
Medical Conditions Targeted
The current clinical trial is focusing on two types of cancer: 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.
Clinical Trial Objectives
The main goal of this clinical trial is to see if EMI-137 can effectively help surgeons visualize cancer during operations. 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: 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: 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). The maximum dose being tested is 0.13 mg per kilogram of body weight, and it's typically given just once before surgery.