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Study on Detecting Sentinel Lymph Nodes in Early Oral Cancer Using Gallium-68-Tilmanocept and Technetium-99m in Patients with Oral Cancer

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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 detecting sentinel lymph nodes in patients with early-stage oral cancer, specifically oral squamous cell carcinoma. The study will use a special imaging technique called PET/CT with a substance known as Gallium-68-Tilmanocept. This substance helps doctors see the lymph nodes more clearly. The trial will also use another substance called Technetium (99mTc) for comparison. Both substances are used to help identify the lymph nodes that may be affected by cancer.

The purpose of the study is to determine how accurately the Gallium-68-Tilmanocept PET/CT can detect these lymph nodes compared to the traditional method using Technetium (99mTc). Participants in the study will undergo imaging with both methods before their surgery. This will help doctors understand which method is better at finding the lymph nodes that need to be examined for cancer spread.

During the study, participants will receive a small amount of the imaging substances near the tumor area. This is done to highlight the lymph nodes during the imaging process. The study aims to improve the way doctors detect and treat oral cancer by finding the most effective method for identifying affected lymph nodes. The trial will help gather important information that could lead to better outcomes for patients with this type 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, you will have already provided written informed consent, confirming your willingness to participate.

    You will have been diagnosed with primary oral squamous cell carcinoma located in specific areas of the mouth, and your clinical stage will have been confirmed as suitable for the study.

  2. Step 2

    Preoperative imaging

    You will undergo a preoperative imaging procedure using Gallium-68-Tilmanocept PET/CT. This imaging helps in detecting sentinel lymph nodes, which are the first nodes to which cancer cells are likely to spread.

    The procedure involves the use of a radioactive substance called Gallium-68, which is injected near the tumor site to help visualize the lymph nodes.

  3. Step 3

    Lymphoscintigraphy

    You will also undergo a conventional imaging procedure called lymphoscintigraphy using Technetium-99m-Tilmanocept. This is another method to detect sentinel lymph nodes.

    The procedure involves the injection of a small amount of radioactive material near the tumor, similar to the PET/CT scan, to help identify the lymph nodes.

  4. Step 4

    Surgical procedure

    Following the imaging procedures, you will undergo a surgical procedure to remove the detected sentinel lymph nodes.

    The removed lymph nodes will be examined to check for the presence of cancer cells.

  5. Step 5

    Postoperative follow-up

    After the surgery, you will have follow-up appointments to monitor your recovery and discuss the results of the lymph node examination.

    These follow-ups are important to ensure your well-being and to provide any necessary additional treatment based on the findings.

Who can join the trial?

8 criteria

  • The patient has provided written informed consent before participating in the study.
  • The patient has a diagnosis of primary oral squamous cell carcinoma, which is a type of oral cancer, located in specific areas of the mouth such as the lip, cheek lining, gums, floor of the mouth, hard palate, or tongue.
  • The cancer stage is classified as T1-T2 or T3 (only if the tumor is larger than 2 cm but not more than 4 cm, with a depth of invasion greater than 10 mm), and there is no spread to lymph nodes (N0) or other parts of the body (M0).
  • The absence of cancer in the lymph nodes has been confirmed by a negative result from a procedure called ultrasound-guided fine needle aspiration cytology within 30 days before the study procedure. This is a test where a thin needle is used to take a sample from the lymph nodes to check for cancer cells.
  • The patient is a candidate for transoral excision, which is a surgical procedure to remove the tumor through the mouth.
  • Patients who had a previous cancer in the head and neck area can participate if they have been treated successfully, are considered at low risk for the cancer coming back, and have had no head and neck cancer for the past five years.
  • The patient is at least 18 years old at the time of giving consent.
  • The patient has an ECOG status of Grade 0 – 2, which is a scale used to assess how well a patient can perform daily activities. Grade 0 means fully active, and Grade 2 means capable of all self-care but unable to carry out any work activities.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides oral cancer cannot participate.
  • Patients who have had previous treatment for oral cancer are not eligible.
  • Patients with severe medical conditions that could interfere with the study are excluded.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who are unable to give informed consent are not allowed to participate.
  • Individuals with known allergies to the study medication or its components are excluded.
  • Patients who are participating in another clinical trial at the same time are not eligible.
  • Patients with a history of drug or alcohol abuse that could affect the study results are excluded.
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Investigated drugs

Gallium-68-Tilmanocept is a special type of imaging agent used in this clinical trial. It helps doctors see certain areas inside the body more clearly during a PET/CT scan. In this study, it is used to detect sentinel lymph nodes in patients with early oral cancer. Sentinel lymph nodes are the first few lymph nodes where cancer is likely to spread. By using Gallium-68-Tilmanocept, doctors aim to improve the accuracy of detecting these lymph nodes before surgery, which can help in planning the best treatment approach for the patient.

What is already known about the treatment

Gallium-68-Tilmanocept – This medication is administered through an injection and is used in a PET/CT scan to help detect sentinel lymph nodes in patients with early oral cancer. Currently, it is being studied in clinical trials to determine its effectiveness in accurately identifying these lymph nodes before surgery. The main therapeutic indication is for the diagnosis and staging of oral cancer. At the molecular level, Gallium-68-Tilmanocept binds to a specific protein found in lymphatic tissue, allowing it to highlight the lymph nodes during imaging. It is classified as a radiopharmaceutical diagnostic agent.

Investigated diseases

Oral cancer – Oral cancer refers to malignant growths found in the mouth, including the lips, tongue, cheeks, floor of the mouth, hard and soft palate, sinuses, and throat. It typically begins as a small, pale, pinkish lump or growth inside the mouth. As it progresses, the lesion may become larger, ulcerated, and more painful. The disease can cause difficulty in chewing, swallowing, or speaking as it advances. It may also lead to numbness or a feeling of something caught in the throat. Over time, oral cancer can spread to other parts of the body, including the lymph nodes in the neck.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-521682-27-00Protocol codeV0001699Estimated enrolment94 patientsSponsorUniversitair Medisch Centrum Utrecht

sourced from the EU Clinical Trials Register and site verification

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