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Study on the Use of Indocyanine Green and Technetium (99mTc) Nanocolloid for Sentinel Node Biopsy in Patients with Melanoma, Oral Cancer, or Penile Cancer

Registered 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 patients with certain types of cancer, specifically melanoma of the head, neck, or upper part of the trunk, oral cancer, and penile cancer. The study is investigating a new method for identifying sentinel nodes, which are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. The treatment being studied involves a combination of two substances: Indocyanine Green and Technetium (99mTc) Nanocolloid. These substances are used together as a hybrid tracer to help locate sentinel nodes during a procedure called a sentinel node biopsy.

The purpose of the study is to validate the effectiveness of this hybrid tracer in accurately identifying sentinel nodes. The study will compare the results of using the hybrid tracer with the standard method, which uses only Technetium (99mTc) Nanocolloid. Participants will receive an injection of the tracer substances, and imaging techniques such as lymphoscintigraphy and SPECT/CT will be used to visualize the sentinel nodes before surgery. The study aims to ensure that the hybrid tracer can reliably identify the same number of sentinel nodes as the standard method.

Throughout the study, researchers will monitor the number and intensity of the nodes detected by both the hybrid tracer and the standard method. This will help determine if the new method is as effective as the current standard in identifying sentinel nodes. The study is expected to provide valuable information that could improve the accuracy of sentinel node biopsies in patients with these types of cancer.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria. This includes being over 18 years old and having a diagnosis of melanoma, oral malignancy, or penile carcinoma, with a scheduled sentinel node biopsy.

  2. Step 2

    Preparation for the procedure

    Before the procedure, a combination of substances is administered intravenously. These include indocyanine green and technetium (99mTc) nanocolloid. These substances help in visualizing the sentinel nodes during imaging.

  3. Step 3

    Imaging

    Preoperative imaging is conducted using lymphoscintigraphy and SPECT/CT. These imaging techniques help in identifying the sentinel nodes, which are the first nodes to which cancer cells are likely to spread.

  4. Step 4

    Sentinel node biopsy

    During the biopsy, the identified sentinel nodes are surgically removed. The procedure uses both fluorescence and radioactive signals to ensure accurate removal of the nodes.

  5. Step 5

    Post-procedure evaluation

    After the procedure, the concordance between the imaging results and the actual findings during surgery is evaluated. This involves comparing the number and intensity of fluorescent and radioactive signals from the nodes.

Who can join the trial?

8 criteria

  • The patient must be scheduled to have a **sentinel node procedure** as part of their regular medical care. This is a procedure to check if cancer has spread to the lymph nodes.
  • The patient must be older than 18 years.
  • The patient must have one of the following conditions:
    • A primary **cutaneous melanoma** on the head, neck, upper part of the trunk, or extremities. This is a type of skin cancer.
    • A primary **oral cavity malignancy** classified as T1-2N0. This means a small cancer in the mouth that has not spread to the lymph nodes.
    • Primary **penile cancer**.
    • The patient must have a **clinical N0 stage**, meaning there is no clinical evidence of cancer in the lymph nodes.
    • The patient must be scheduled for a **sentinel node biopsy** before any further surgery to remove the primary cancer.
    • The patient must be in a situation where the use of **ICG-99mTc-nanoscan** is part of their routine care or a research setting. This is a special imaging technique used to help find sentinel nodes.

Who cannot join the trial?

4 criteria

  • Patients with **melanoma** of the head/neck or the upper part of the trunk cannot participate. **Melanoma** is a type of skin cancer.
  • Patients with **oral malignancies** are excluded. **Oral malignancies** refer to cancerous growths in the mouth.
  • Patients with **penile carcinoma** cannot join. **Penile carcinoma** is a type of cancer that affects the penis.
  • Patients who are not scheduled for a **sentinel node (SN) biopsy** are excluded. A **sentinel node biopsy** is a procedure to check if cancer has spread to the lymph nodes.
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Investigated drugs

  • ICG-99mTc-nanoscan

    is a hybrid tracer used in medical imaging to help locate sentinel lymph nodes. It combines two components: a fluorescent dye (ICG) and a radioactive tracer (99mTc). This combination allows doctors to visualize the lymph nodes using both fluorescence and radioactivity, improving the accuracy of detecting sentinel nodes during procedures.

  • 99mTc-nanoscan

    is a radioactive tracer used in medical imaging to identify sentinel lymph nodes. It emits radiation that can be detected by special cameras, helping doctors to locate these important nodes before surgery. This tracer is used to ensure that the correct lymph nodes are identified and examined.

What is already known about the treatment

ICG-99mTc-nanoscan – This medication is administered as an injection and is used in sentinel node biopsy procedures. It is currently being studied in clinical trials to validate its effectiveness as a hybrid tracer for detecting sentinel nodes in patients with certain types of cancer, such as melanoma, oral malignancies, and penile carcinoma. The main therapeutic indication is to assist in identifying sentinel nodes during preoperative imaging, which helps in cancer staging and treatment planning. At the molecular level, it combines a fluorescent dye (ICG) and a radioactive tracer (99mTc) to enhance visualization of lymph nodes using imaging techniques like SPECT/CT. It is classified as a diagnostic agent in the field of nuclear medicine.

Investigated diseases

  • Melanoma

    Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new or unusual growth or a change in an existing mole. Melanoma can occur anywhere on the skin but is most common on the head, neck, or trunk. It can spread to other parts of the body if not detected early. The progression of melanoma involves changes in the size, shape, or color of a mole or skin lesion. Early detection is crucial to prevent further spread.

  • Oral Cancer

    Oral cancer refers to cancer that develops in any part of the mouth, including the lips, gums, tongue, and inner lining of the cheeks. It often begins as a sore or growth that does not heal. The disease can progress by invading nearby tissues and spreading to other areas of the body. Risk factors include tobacco use, heavy alcohol consumption, and human papillomavirus (HPV) infection. Symptoms may include persistent mouth pain, difficulty swallowing, and changes in speech. Early detection is important to manage the disease effectively.

  • Penile Cancer

    Penile cancer is a rare type of cancer that occurs on the skin or in the tissues of the penis. It often starts as a lump, ulcer, or wart-like growth on the penis, which may be accompanied by changes in color or thickness of the skin. The disease can progress by spreading to nearby lymph nodes and other parts of the body. Risk factors include human papillomavirus (HPV) infection, smoking, and poor hygiene. Symptoms may include bleeding, discharge, and pain in the affected area. Early diagnosis is key to preventing further progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519351-28-00Estimated enrolment29 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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