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

2 1 1

What is this study about?

This clinical trial is focused on studying two types of cancer: penile cancer and tongue cancer. The treatment being tested is a new medication called EMI-137, which is a special type of protein linked to a dye. This medication is given as a powder that is mixed and then injected into the bloodstream. The purpose of the study is to see if this medication can help doctors see the cancer better during surgery by making the cancer cells light up.

During the study, patients who have either penile or tongue cancer and are scheduled for surgery will receive an injection of EMI-137. This medication is designed to attach to a specific part of the cancer cells called the c-Met receptor, which is often found in these types of cancers. When the medication attaches to the cancer cells, it makes them glow under a special light, helping surgeons to see the cancer more clearly during the operation.

The study will also look at whether this glowing effect can help identify cancer that has spread to nearby lymph nodes or detect early changes in the tissue that might turn into cancer. The results of the glowing effect will be compared to traditional methods used to study cancer cells in the lab. This research aims to improve the way surgeons can see and remove cancer during surgery, potentially leading to better outcomes for patients with penile and tongue cancer.

1 joining the study

Participation begins after providing written informed consent. This is a formal agreement to participate in the study after understanding all the procedures involved.

Eligibility requires being 18 years or older and having a diagnosis of T1 or higher stage penile or tongue squamous cell cancer. The patient must be scheduled for surgical removal of the primary tumor.

2 preparation for medication

The medication used in this study is called EMI-137. It is a powder that is prepared for injection.

The medication is administered through an intravenous bolus injection or IV infusion. This means it is given directly into a vein.

3 administration of medication

The purpose of administering EMI-137 is to enable the visualization of tumors during surgery. This is achieved through a process called fluorescence imaging, which helps in identifying the tumor more clearly.

4 surgical procedure

During the surgery, the primary tumor is removed. The fluorescent imaging technique is used to visualize the tumor and potentially affected lymph nodes.

The imaging results are compared with the level of c-MET expression, which is a protein that may be present in the tumor, using a standard laboratory method called immunohistochemistry.

5 post-surgery evaluation

After the surgery, the effectiveness of the imaging technique is evaluated. This includes checking for the presence of any remaining cancerous tissue or dysplasia, which is a precancerous condition.

The study also aims to detect and visualize any lymph node metastases, which are cancer cells that have spread to the lymph nodes.

Who Can Join the Study?

Provide a signed document that shows you understand and agree to participate in the study before any study-related activities begin.
Be at least 18 years old when you join the study.
Have a diagnosis of T1 squamous cell cancer of the penis or tongue. T1 means the cancer is in its early stage and has not spread deeply.
Be scheduled for surgery to remove the main tumor.

Who Cannot Join the Study?

Individuals who are not diagnosed with penile carcinoma or tongue carcinoma cannot participate. Carcinoma is a type of cancer that starts in the skin or the tissue lining organs.
Participants must be within the specified age range. If you are not within this range, you cannot participate.
Both male and female participants are eligible, but if you do not identify as either, you may not be able to participate.
Individuals considered part of a vulnerable population are not eligible. This typically includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Netherlands Cancer Institute	Amsterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.10.2019

Trial locations

Investigated drugs:

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

Fluorescent C-Met Tracer is a special imaging agent used during surgery to help doctors see cancerous tumors more clearly. It works by attaching to specific receptors on the cancer cells, making them glow under a special light. This helps surgeons identify and remove the tumors more accurately, especially in penile and tongue cancers.

Investigated diseases:

Penile Carcinoma – This is a type of cancer that occurs on the skin or in the tissues of the penis. It often begins as a small lesion or sore that may not heal and can grow over time. The disease can progress by invading deeper tissues and potentially spreading to nearby lymph nodes. It is more common in older men and can be associated with certain risk factors like HPV infection. As it advances, it may cause symptoms such as pain, bleeding, or discharge from the affected area. Early detection is crucial for managing its progression.

Tongue Carcinoma – This cancer develops in the cells of the tongue, often starting as a small, persistent sore or lump. It can affect the front part of the tongue or the base, which is closer to the throat. As it progresses, it may cause difficulty in speaking, swallowing, or changes in taste. The disease can spread to nearby tissues and lymph nodes, leading to more severe symptoms. Risk factors include tobacco use, alcohol consumption, and HPV infection. Early signs may include a red or white patch on the tongue that does not go away.

Trial ID:

2024-518046-25-00

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?