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Study on Sentinel Lymph Node Biopsy for Parotid Gland Cancer Using Gallium (68Ga) Chloride and Tilmanocept in Patients Undergoing Parotidectomy and Neck Dissection

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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 called carcinoma of the parotid gland, which affects the salivary glands located near the ear. The study aims to explore a procedure known as sentinel lymph node biopsy (SLNB) in patients who are scheduled for surgery to remove the parotid gland and possibly some lymph nodes in the neck. The procedure involves using a combination of two substances: 99mTc-nanocolloid and 68Ga-tilmanocept, which are used in a special type of imaging called PET/CT to help identify the lymph nodes that may be affected by cancer.

The purpose of the study is to determine if this method can effectively identify the sentinel lymph nodes in patients with parotid gland carcinoma. During the study, patients will undergo the SLNB procedure, and the researchers will use the imaging technique to locate the lymph nodes. The goal is to see if the imaging can successfully identify these nodes in at least 8 out of 10 patients. The study will also compare the results of the lymph node biopsy with the results from the neck dissection surgery to check for the presence of cancer cells.

Additionally, the study will look into the best timing for the PET/CT imaging and assess any complications that may occur after the surgery. The findings from this study could help improve the way doctors identify and treat lymph nodes affected by cancer in patients with parotid gland carcinoma.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of primary carcinoma of the parotid gland and ensuring the patient is a candidate for parotidectomy and elective neck dissection.

    Clinical nodal staging is confirmed as negative through imaging tests such as CT, MRI, PET/CT, or ultrasound-guided fine needle aspiration cytology.

  2. Step 2

    Preparation for sentinel lymph node biopsy

    The patient is prepared for the sentinel lymph node biopsy (SLNB) procedure. This involves the use of 68Ga-tilmanocept and 99mTc-nanocolloid for imaging.

    The 68Ga-tilmanocept is administered peritumorally, meaning it is injected around the tumor area to help identify sentinel lymph nodes using PET/CT imaging.

  3. Step 3

    Sentinel lymph node biopsy procedure

    During the SLNB procedure, the sentinel lymph nodes are identified using PET/CT lymphoscintigraphy. The goal is to detect these nodes in at least 8 out of 10 patients.

    Once identified, the sentinel lymph nodes are surgically removed for further examination.

  4. Step 4

    Postoperative evaluation

    After the SLNB procedure, the excised lymph nodes are analyzed for the presence of tumor cells or metastasis.

    The results are compared with those from the elective neck dissection specimens to assess the accuracy and effectiveness of the SLNB.

  5. Step 5

    Monitoring and follow-up

    The patient is monitored for any postoperative complications, which are graded using the Clavien-Dindo classification of surgical complications.

    Regular follow-up appointments are scheduled to ensure recovery and to address any concerns that may arise during the postoperative period.

Who can join the trial?

7 criteria

  • The patient must provide written consent to participate in the study.
  • The patient must have a diagnosis of primary **carcinoma of the parotid gland**. This means they have a type of cancer that starts in the parotid gland, which is a salivary gland located near the ear.
  • The cancer must be at a stage between T1 and T4, cN0, M0. This refers to the size and extent of the cancer and whether it has spread to nearby lymph nodes or other parts of the body.
  • The patient must have a clinical nodal staging of cN0, meaning no cancer is found in the lymph nodes, confirmed by tests like CT, MRI, PET/CT, or ultrasound-guided fine needle aspiration cytology within 30 days before the procedure.
  • The patient must be a candidate for **parotidectomy** and **elective neck dissection**. Parotidectomy is a surgery to remove the parotid gland, and elective neck dissection is a surgery to remove lymph nodes in the neck.
  • The patient must be 18 years of age or older at the time of giving consent.
  • The patient must have an **ECOG status** of Grade 0 to 2. ECOG status is a scale used to assess how a patient's disease is affecting their daily living abilities, with 0 being fully active and 2 being able to do all self-care but unable to carry out any work activities.

Who cannot join the trial?

5 criteria

  • Patients who are not scheduled for a surgery called parotidectomy, which is a procedure to remove the parotid gland.
  • Patients who are not scheduled for elective neck dissection, a surgery to remove lymph nodes in the neck area.
  • Patients who are not diagnosed with carcinoma of the parotid gland, which is a type of cancer affecting the parotid gland.
  • Patients who are under the age of 18 or over the age of 65.
  • Patients who belong to vulnerable populations, which means groups that might need special protection or care.
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Investigated drugs

  • 99mTc-nanocolloid

    is a radioactive tracer used in medical imaging. In this trial, it helps doctors identify sentinel lymph nodes, which are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. By injecting this tracer, doctors can see the lymph nodes on imaging scans and determine if cancer has spread.

  • 68Ga-tilmanocept

    is another imaging agent used in this study. It is designed to bind to specific receptors on the surface of certain cells, making it easier to visualize lymph nodes during a PET/CT scan. This helps in accurately identifying the sentinel lymph nodes for biopsy, which is crucial for assessing the spread of cancer in patients with parotid gland carcinoma.

What is already known about the treatment

  • 99mTc-nanocolloid

    This medication is administered through injection and is used in imaging procedures. It is currently being studied in clinical trials for its effectiveness in identifying sentinel lymph nodes in patients with parotid gland carcinoma. The main therapeutic indication is to assist in the detection of lymph nodes that may be affected by cancer. At the molecular level, it works by binding to particles that accumulate in lymph nodes, allowing them to be visualized using imaging techniques. It is classified as a radiopharmaceutical agent.

  • 68Ga-tilmanocept

    This medication is also administered via injection and is used in conjunction with PET/CT imaging. It is under investigation in clinical trials for its role in sentinel lymph node biopsy in patients with parotid gland carcinoma. The primary therapeutic indication is to help locate lymph nodes that could be involved in cancer spread. Its mechanism of action involves targeting specific receptors on immune cells within lymph nodes, enabling precise imaging. It is classified as a diagnostic radiopharmaceutical.

Investigated diseases

Carcinoma of the parotid gland – This is a type of cancer that occurs in the parotid glands, which are the largest of the salivary glands located near the jaw and in front of the ears. The disease begins when cells in the parotid gland grow uncontrollably, forming a tumor. As the carcinoma progresses, it may invade nearby tissues and structures, potentially affecting facial nerves and causing facial weakness or paralysis. The cancer can also spread to nearby lymph nodes and other parts of the body. Symptoms may include a lump or swelling near the jaw or neck, pain, and difficulty swallowing. The progression of the disease can vary depending on the specific type and aggressiveness of the carcinoma.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514233-37-00Estimated enrolment10 patientsSponsorUniversitair Medisch Centrum Utrecht

sourced from the EU Clinical Trials Register and site verification

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