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Study on Using Perflubutane for Sentinel Node Detection in Patients with Breast Cancer, Melanoma, or Head and Neck 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 breast cancer, melanoma, or head & neck cancer. The study will use a special imaging technique called contrast-enhanced ultrasound (CEUS) to help detect sentinel nodes, which are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. The treatment involves an injection of a contrast agent known as Sonazoid, which contains the active substance perflubutane. This contrast agent helps to improve the visibility of the lymph nodes during the ultrasound procedure.

The purpose of the study is to evaluate how well CEUS can identify sentinel nodes during surgery compared to the current standard method. Participants will undergo a procedure where the Sonazoid contrast agent is injected, and the sentinel nodes are then located using the CEUS technique with the help of a device called the BK5000 US device. This study aims to determine the accuracy of CEUS in finding these nodes and to see if it can predict whether the nodes are cancerous.

Throughout the study, researchers will monitor the time it takes to locate the sentinel nodes using CEUS and assess the ease of using the CEUS system. The study will provide valuable information on whether this method can be a reliable alternative to existing techniques for detecting sentinel nodes in patients with these types of cancer.

The research process

The trial runs in 4 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, ensure that all eligibility criteria are met. This includes being 18 years or older, having a diagnosis of breast cancer, melanoma, or head & neck cancer, and being scheduled for a surgical procedure to locate sentinel nodes (SN).

    Provide written informed consent to participate in the study.

  2. Step 2

    Preparation for procedure

    Before the procedure, receive an injection of a special substance called Sonazoid, which contains perflubutane. This is used to enhance ultrasound images and is administered directly into the tumor area.

    The injection is a dispersion for injection, meaning it is a liquid preparation designed to be injected into the body.

  3. Step 3

    Undergoing the procedure

    During the procedure, a technique called contrast-enhanced ultrasound (CEUS) is used. This helps in locating the sentinel nodes, which are the first lymph nodes to which cancer cells are likely to spread.

    The goal is to assess how accurately CEUS can identify these nodes compared to the standard method using a radioactive substance.

  4. Step 4

    Post-procedure evaluation

    After the procedure, the time taken to locate the sentinel nodes using CEUS is recorded.

    The usability of the CEUS system is evaluated using a specific scoring system to determine how user-friendly the system is.

    The accuracy of CEUS in predicting whether the sentinel nodes are cancerous is also assessed.

Who can join the trial?

5 criteria

  • Aged 18 years or older
  • Patient has been diagnosed with cancer in the skin (melanoma), breast, or head & neck (including melanoma of head and neck area)
  • In case of a melanoma: it should be located in the limbs or head and neck area
  • Scheduled for a surgical SN procedure (a type of surgery to check lymph nodes) at the NKI-AvL
  • Patient provides written informed consent (agreement to participate after understanding the study)

Who cannot join the trial?

3 criteria

  • Patients with **breast cancer** cannot participate.
  • Patients with **melanoma** cannot participate.
  • Patients with **head & neck cancer** cannot participate.
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Investigated drugs

  • Contrast-enhanced ultrasound (CEUS)

    is a special type of ultrasound that uses a contrast agent to help doctors see certain areas of the body more clearly. In this trial, CEUS is used to help locate sentinel nodes, which are the first lymph nodes to which cancer cells are likely to spread from a primary tumor. By enhancing the ultrasound images, doctors can better identify these nodes during surgery, which can help in planning the best treatment for patients with melanoma, breast cancer, or head and neck cancer.

  • 99mTc nanocolloid

    is a radioactive substance used in medical imaging. It is considered the gold standard for locating sentinel nodes in cancer patients. During the procedure, this substance is injected near the tumor site, and it travels to the sentinel nodes. Doctors then use a special camera to detect the radiation and identify the nodes. This helps them determine if cancer has spread and decide on the best course of treatment.

What is already known about the treatment

Contrast-enhanced ultrasound (CEUS) – This medication is administered through an ultrasound procedure, where a contrast agent is injected to enhance the imaging of lymph nodes. It is currently being studied in clinical trials for its effectiveness in detecting sentinel nodes in patients with melanoma, breast cancer, or head and neck cancer. The main therapeutic indication is to improve the accuracy of identifying sentinel nodes during surgery, which is crucial for cancer staging and treatment planning. At the molecular level, the contrast agent used in CEUS enhances the ultrasound signal, making it easier to visualize the lymph nodes. CEUS falls under the pharmacological classification of diagnostic imaging agents.

Investigated diseases

  • Breast Cancer

    Breast cancer is a disease where cells in the breast grow uncontrollably. It typically begins in the ducts or lobules of the breast. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The growth of cancer cells can form a lump or mass in the breast. Over time, the cancer may invade surrounding tissues and organs. The progression can vary greatly among individuals.

  • Melanoma

    Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new mole or a change in an existing mole. As melanoma progresses, it can spread to other parts of the skin and internal organs. The disease can grow quickly and become more difficult to treat as it advances. Melanoma can occur on any skin surface, but it is more common in areas exposed to the sun. The progression rate can differ based on various factors, including genetic predisposition.

  • Head and Neck Cancer

    Head and neck cancer refers to a group of cancers that originate in the tissues and organs of the head and neck region. These cancers can develop in areas such as the throat, larynx, nose, sinuses, and mouth. As the disease progresses, it can spread to nearby lymph nodes and other parts of the body. The growth of cancerous cells can lead to the formation of tumors in the affected areas. Over time, these tumors may invade surrounding tissues and structures. The progression can vary depending on the specific location and type of cancer.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2024-515259-40-00Estimated enrolment91 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

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