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A Study Using Indocyanine Green Fluorescence Imaging to Help Surgeons Better Identify Tumor Edges During Cancer Surgery in Patients with Solid Tumors

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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 studying various types of solid malignancy, which means cancers that form solid tumors rather than blood cancers. These include cancers of the head and neck, digestive system, liver and bile ducts, breast, urinary and reproductive organs, and sarcomas, which are cancers that develop in bones or soft tissues like muscles and fat. The treatment being used in this study is indocyanine green, a substance that glows under special light and is given through a vein. The medicine being studied is called VERDYE, which contains indocyanine green as its active ingredient.

The purpose of this study is to find the best amount and timing of indocyanine green to create enough difference in brightness between the tumor and normal tissue, and to check whether this glowing effect can help surgeons accurately identify the edges of tumors during surgery. The study will look at how well the fluorescence imaging, which is a technique that uses special cameras to see the glowing substance, matches with what is found when tissue is examined under a microscope after removal. Researchers will also count how many additional glowing areas are found and confirmed to be cancer, as well as cases where the glow incorrectly suggests cancer when there is none or misses cancer that is present.

During the study, patients who are already planned to have surgery to remove their cancer will receive an infusion of indocyanine green before or during their operation. Surgeons will use special cameras that can detect the fluorescence to look at the tumor area and the surrounding tissue. The removed tissue and any lymph nodes will be examined both with the fluorescence camera and later under a microscope to compare the results. The study will measure the brightness difference between tumor and normal tissue, check whether the edges of the removed tissue are free of cancer cells, and record any side effects that occur. The goal is to determine if this imaging method can help surgeons remove cancer more completely while preserving healthy tissue.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Screening and enrollment

    Your doctor will confirm that you have a solid tumor that has been verified through tissue examination. This may include tumors in areas such as the head and neck, digestive system, liver and bile ducts, breast, urinary and reproductive organs, or soft tissue and bone tumors.

    Your doctor will verify that you are at least 18 years old and that you are scheduled for surgery to remove the tumor with the goal of curing your condition.

    Tests will be performed to ensure that your organs are functioning well enough to safely undergo surgery and receive the imaging substance called indocyanine green.

    You will be asked to provide written consent to participate in this study after receiving detailed information about the procedures involved.

  2. Step 2

    Administration of imaging substance

    Before your surgery, you will receive an intravenous infusion of indocyanine green, which is a special dye that helps make tumor tissue visible under special lighting during the operation.

    The product used is called VERDYE 5 mg/ml powder for solution for injection.

    The exact dose and timing of when you receive this substance will be determined by the study protocol to find the best combination for seeing the tumor clearly during surgery.

  3. Step 3

    Surgical procedure with fluorescence imaging

    During your surgery, the surgical team will use special imaging equipment that can detect the fluorescent signal from the indocyanine green in your body.

    This fluorescence imaging will help the surgeon identify the edges of the tumor and distinguish between tumor tissue and healthy tissue.

    The surgeon may use this imaging to check the surgical area and the tissue that has been removed to ensure complete removal of the tumor.

    If additional areas show fluorescence signals, the surgeon may take small tissue samples from these areas to determine if they contain tumor cells.

  4. Step 4

    Tissue examination

    The tissue removed during your surgery will be examined in the laboratory to confirm whether the edges of the removed tissue are free of tumor cells.

    Laboratory specialists will compare the areas that showed fluorescence signals with the microscopic examination results to determine how accurately the imaging identified tumor tissue.

    If lymph nodes were removed during your surgery, they will be examined to measure the fluorescence intensity and determine whether they contain tumor cells.

  5. Step 5

    Safety monitoring

    Throughout the study, you will be monitored for any unwanted effects or complications related to the indocyanine green administration or the surgical procedure.

    Any side effects, whether mild or serious, will be recorded and assessed by your medical team.

    Your doctor will track your recovery and overall health status according to standard medical care protocols.

Who can join the trial?

5 criteria

  • You must be 18 years of age or older
  • You must have a solid malignancy, which is a cancerous tumor that has been confirmed through histological examination (tissue sample examined under a microscope). This includes cancers of the head and neck, digestive system, liver and bile ducts, breast, urinary and reproductive organs, or sarcoma (cancer of connective tissues like bone or muscle)
  • You must be a candidate for surgical resection, which means your doctor has determined that surgery to remove the tumor is a suitable treatment option for you with the goal of curing the disease
  • You must be able to understand and sign a written informed consent, which is a document explaining the study and confirming you agree to participate
  • You must have adequate organ function, meaning your body organs such as liver, kidneys, and heart work well enough for you to safely undergo surgery and receive ICG (a fluorescent dye used during the procedure)

Who cannot join the trial?

8 criteria

  • You are pregnant, which means carrying a developing baby in your body
  • You are breastfeeding, which means feeding a baby with milk from your breast
  • You have a known allergy to indocyanine green (ICG), which is a special green dye that will be used during the study to help doctors see the tumor better
  • You have a known allergy to iodine, which is a substance found in some foods and medical products
  • You have severe liver disease, which means your liver (the organ that cleans your blood and helps digest food) is not working properly
  • You have severe kidney disease, which means your kidneys (the organs that filter waste from your blood and make urine) are not working properly
  • You have an overactive thyroid, which means your thyroid gland (a small organ in your neck that controls how your body uses energy) is producing too much hormone
  • You are unable to give informed consent, which means you cannot understand the study information and make a decision about joining on your own
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Investigated drugs

Indocyanine green is a dye that is injected into the bloodstream and makes certain tissues glow under special light during surgery. In this trial, doctors will use this dye to help them see the edges of tumors more clearly during an operation. The glowing effect helps surgeons tell the difference between cancer tissue and healthy tissue, which may help them remove the tumor more completely.

What is already known about the treatment

Indocyanine Green – Indocyanine green is a fluorescent dye that is given through an intravenous injection into a vein, used during surgery to help doctors see tumors more clearly under special imaging equipment. This medication is already approved and used in medicine for various purposes, including examining blood flow and identifying tissues during surgical procedures. In this clinical trial, it is being studied to find the best dose and timing to create a clear contrast between solid tumors (such as cancers of the head and neck, digestive system, liver, breast, urinary organs, and soft tissues) and surrounding healthy tissue, helping surgeons identify and remove cancer more precisely. The dye works by accumulating in tumor tissue and glowing under near-infrared light, making cancer cells visible to the surgical team in real-time during the operation.

Investigated diseases

  • Head and Neck Cancer

    Head and neck cancer refers to a group of cancers that develop in the tissues and organs of the head and neck region, including the mouth, throat, voice box, nose, and salivary glands. These cancers typically begin in the cells that line the moist surfaces inside these areas. The disease often starts as abnormal cell growth that can form tumors in the affected tissues. As the cancer progresses, it may grow larger and invade nearby structures such as muscles, bones, and nerves. In more advanced stages, cancer cells can spread to lymph nodes in the neck or to other parts of the body.

  • Gastrointestinal Cancer

    Gastrointestinal cancer encompasses cancers that occur anywhere along the digestive tract, including the esophagus, stomach, small intestine, colon, and rectum. The disease begins when normal cells in the digestive system undergo changes and start to grow uncontrollably, forming tumors. Early stages may involve small growths or polyps that can develop into cancer over time. As the disease advances, the tumor can grow through the layers of the digestive tract wall. The cancer may also spread to nearby lymph nodes and eventually to distant organs if it continues to progress.

  • Hepatobiliary Cancer

    Hepatobiliary cancer refers to cancers affecting the liver, gallbladder, and bile ducts, which are the tubes that carry bile from the liver to the intestines. These cancers develop when cells in these organs begin to multiply abnormally and form malignant tumors. The disease can originate directly in the liver or bile ducts, or less commonly in the gallbladder. As hepatobiliary cancer progresses, it can grow within the affected organ and block bile flow, particularly in bile duct cancers. Advanced disease may spread to nearby blood vessels, lymph nodes, and other abdominal organs.

  • Breast Cancer

    Breast cancer is a disease in which cells in the breast tissue grow abnormally and form a tumor that can be felt as a lump or seen on imaging tests. The cancer most commonly begins in the milk ducts or the glands that produce milk. Initially, the abnormal cells may remain confined to the ducts or glands, but over time they can break through and invade surrounding breast tissue. As the disease progresses, cancer cells may travel through the lymphatic system to nearby lymph nodes, particularly those under the arm. In more advanced stages, the cancer can spread through the bloodstream to other parts of the body such as bones, lungs, or liver.

  • Genitourinary Cancer

    Genitourinary cancer includes cancers that develop in the urinary system and reproductive organs, such as the kidneys, bladder, prostate, testicles, ovaries, and uterus. These cancers begin when normal cells in these organs undergo genetic changes and start to divide uncontrollably. The disease typically starts in the lining or tissue of the affected organ and forms a tumor. As genitourinary cancers grow, they can invade deeper layers of the organ wall and extend into surrounding tissues. The progression may involve spread to nearby lymph nodes and, in advanced cases, to distant organs through the bloodstream.

  • Sarcoma

    Sarcoma is a type of cancer that develops in the connective tissues of the body, including muscles, fat, blood vessels, nerves, tendons, and the lining of joints. Unlike more common cancers that start in organs, sarcomas arise from the cells that support and connect other body tissues. The disease begins when these connective tissue cells start to grow abnormally and form a mass or tumor. Sarcomas can occur anywhere in the body but are most commonly found in the arms, legs, and abdomen. As the tumor grows, it can push against and invade nearby structures, and may eventually spread to other parts of the body, most often the lungs.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-523898-42-00Estimated enrolment40 patientsSponsorErasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

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