Recruiting

Study on Using Indocyanine Green for Detecting Residual Disease in Head and Neck Cancer Surgery

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as epidermoid carcinoma, which affects areas like the mouth and throat. The study is exploring the use of a special imaging technique during surgery to help doctors see if any cancer cells are left behind after the main tumor is removed. This technique uses a substance called indocyanine green, which is injected into the body and helps highlight cancer cells when viewed with a special camera that uses near-infrared light.

The purpose of the study is to see how well this imaging method can detect tiny amounts of cancer that might remain after surgery. During the trial, participants will undergo surgery to remove the cancer, and the imaging technique will be used to check the surgical area for any remaining cancer cells. This will help doctors ensure that as much of the cancer as possible is removed during the operation.

Participants in the study may receive either the imaging technique with indocyanine green or a placebo. The study will monitor the effectiveness of the imaging method in identifying cancer cells and will also track any side effects experienced by participants. The goal is to improve surgical outcomes for patients with epidermoid carcinoma by providing surgeons with better tools to ensure all cancerous tissue is removed.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be required to sign an informed consent form. This form confirms that you understand the study and agree to participate.
You must be at least 18 years old, have a confirmed diagnosis of epidermoid carcinoma in the oral cavity or oropharynx, and be eligible for surgery with the goal of complete removal of the tumor.
Step 2
Pre-operative visit
Before the surgery, a pre-operative visit will be scheduled. During this visit, a pregnancy test will be conducted for women of childbearing potential.
This visit will occur within 14 days before the administration of the study medication.
Step 3
Medication administration
You will receive an injection of indocyanine green, a dye used for imaging purposes. This will be administered intravenously as a solution for injection.
The medication is called INFRACYANINE 25 mg/10 mL.
Step 4
Surgery and imaging
During the surgery, near-infrared fluorescence imaging will be used to help detect any remaining cancer cells in the tissue that is removed.
This imaging technique aims to ensure that all cancerous tissue is successfully removed.
Step 5
Post-operative evaluation
After the surgery, the removed tissue will be examined to confirm the presence or absence of microscopic residual disease.
The effectiveness of the imaging technique will be evaluated based on its ability to detect any remaining cancer cells.
Step 6
Follow-up and monitoring
You will be monitored for any adverse events or side effects related to the study medication and procedure.
The study will assess the safety and tolerability of the imaging technique and medication.

Who can join the trial?

9 criteria

Must be a male or female who is 18 years of age or older.
Must have an ECOG performance status of 0-2. This is a scale used to assess how a disease affects a patient's daily living abilities, where 0 means fully active and 2 means capable of all self-care but unable to carry out any work activities.
Must have a histological confirmation of epidermoid carcinoma. This means that a tissue sample has been examined under a microscope to confirm the presence of this type of cancer.
The primary tumor must be located in the oral cavity or oropharynx. The oral cavity includes the mouth, and the oropharynx is the part of the throat at the back of the mouth.
Must have operable disease with the intention of complete resection. This means the cancer can be surgically removed.
For women of childbearing potential, a negative pregnancy test is required within 14 days before the procedure involving the injection of a substance called indocyanine green.
Must have signed an informed consent form. This means the patient understands the study and agrees to participate.
Must be affiliated with a social security plan or a similar plan.
Must be able and willing to comply with study visits and procedures as outlined in the study protocol.

Who cannot join the trial?

4 criteria

Patients with a history of **epidermoid carcinoma** cannot participate. This is a type of cancer that starts in the cells that make up the outer layer of the skin or the lining of some organs.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for specific types of participants.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.

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Institut Gustave Roussy
Verified
Villejuif, France

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Investigated drugs

Indocyanine Green is a special dye used in medical imaging. In this clinical trial, it is used to help doctors see if there are any tiny bits of cancer left in the tissue after surgery for head and neck cancer. The dye is injected into the body, and it lights up under a special camera that uses near-infrared light. This helps the doctors to see the cancerous areas more clearly during the operation, making it easier to ensure that all the cancer is removed.

Indocyanine Green

What is already known about the treatment

Indocyanine Green – Indocyanine Green is administered intravenously and is used in combination with near-infrared fluorescence imaging during surgery. It is currently being studied for its effectiveness in helping surgeons identify and remove all cancerous tissue in patients with head and neck cancers, specifically epidermoid carcinoma. The main therapeutic indication is to assist in the visualization of surgical margins to ensure complete removal of cancerous tissue. At the molecular level, Indocyanine Green works by absorbing near-infrared light and emitting fluorescence, which helps highlight areas of interest during surgery. It is classified as a diagnostic agent in pharmacology.

Investigated diseases

Epidermoid carcinoma – Epidermoid carcinoma, also known as squamous cell carcinoma, is a type of cancer that begins in the squamous cells, which are flat cells found in the skin and the lining of some organs. It often occurs in areas exposed to sunlight, such as the skin, lips, and mouth, but can also develop in other parts of the body, including the throat and lungs. The disease progresses as the cancerous cells grow uncontrollably, forming a mass or tumor. As it advances, the carcinoma can invade nearby tissues and spread to other parts of the body through the lymphatic system or bloodstream. The progression can lead to symptoms such as persistent sores, lumps, or changes in the skin or mucous membranes. Early detection and monitoring are crucial to managing the disease effectively.