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Study on Sentinel Lymph Node Mapping Using Gallium-68 Chloride and Tilmanocept in Patients with High-Risk Endometrial 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 studying endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study is specifically looking at patients with high or high-intermediate risk stages of this cancer. The treatment being investigated involves a special imaging technique using a substance called Gallium-68-tilmanocept. This substance is used in a type of scan called PET/CT, which helps doctors see certain areas inside the body more clearly.

The purpose of the study is to see if this imaging method can effectively map the sentinel lymph nodes, which are the first few lymph nodes where cancer is likely to spread. During the study, participants will undergo a PET/CT scan with Gallium-68-tilmanocept to detect these lymph nodes. The study will also compare the results of this scan with another method that uses a different substance called ICG and a special light to see the lymph nodes during surgery.

Throughout the study, researchers will also look at the condition of the lymph nodes to see if they contain cancer cells. They will check for any side effects that might occur from the imaging process. The study aims to provide more information on how well this new imaging technique works for patients with endometrial cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: having stage I-II high or high-intermediate risk endometrial cancer, being scheduled for robot-assisted pelvic and para-aortic staging, and being at least 18 years old with the ability to provide informed consent.
Step 2
Preparation for procedure
Preparation involves understanding the procedure of sentinel lymph node (SLN) mapping using 68Ga-tilmanocept with PET/CT imaging. This step is crucial for detecting lymph nodes that may be affected by cancer.
Step 3
Administration of medication
The medication gallium (68Ga) chloride and tilmanocept is administered through intracervical use. This means it is injected into the cervix to help in mapping the lymph nodes.
Step 4
PET/CT imaging
A PET/CT scan is performed to visualize the lymph nodes. The goal is to detect a PET-avid node, which indicates the presence of a sentinel lymph node.
Step 5
Evaluation of results
The primary focus is on the feasibility of the SLN procedure using 68Ga-tilmanocept PET/CT. This involves assessing the detection rate of the sentinel lymph nodes.
Step 6
Comparison and assessment
The study also investigates the correlation between SLN detection rates and their anatomical locations using preoperative PET/CT versus intraoperative imaging with a different method. Additionally, the pathological status of the SLNs is assessed to determine if they are tumor-negative or contain various sizes of metastases.
Step 7
Monitoring for adverse events
Adverse events related to the SLN mapping procedure are monitored up to one hour after the PET/CT scan. These events are graded according to a standardized criteria.

Who can join the trial?

6 criteria

The patient must have been diagnosed with **endometrial cancer** or **uterine cancer**. These are types of cancer that affect the lining of the uterus.
The cancer should be at **stage I-II** according to the **FIGO 2012** classification, which means it is in the early stages but considered high or high-intermediate risk. FIGO is a system used to describe how much cancer has spread.
The patient should be scheduled for a **robot-assisted full pelvic and para-aortic staging**. This is a surgical procedure to check the extent of cancer spread in the pelvic and para-aortic areas.
The patient must be **18 years or older**.
The patient must be able to provide **informed consent**, meaning they understand the study and agree to participate.
Only **female** patients are eligible for this study.

Who cannot join the trial?

6 criteria

Patients who do not have **endometrial cancer** or **uterine cancer** cannot participate. These are types of cancer that affect the lining of the uterus.
Only patients with **stage I-II high/high-intermediate risk** endometrial cancer are eligible. This refers to the early stages of cancer with a certain level of risk.
Participants must be within a specific age range, typically adults and older adults.
Only **female** patients are eligible for this study.
**Male** patients cannot participate in this study.
Patients who are considered part of a **vulnerable population** are not eligible. This means individuals who might need special protection or care.

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Responsive
Universitair Medisch Centrum Utrecht
Utrecht, The Netherlands

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Investigated drugs

Gallium-68-tilmanocept is a special imaging agent used in this study. It helps doctors see the lymph nodes more clearly during a PET/CT scan. This is important for patients with certain types of endometrial cancer, as it helps in mapping the sentinel lymph nodes, which are the first few lymph nodes where cancer is likely to spread. This imaging agent is used to check if the cancer has spread to these lymph nodes, which can help in planning the best treatment approach.

What is already known about the treatment

Gallium-68 Tilmanocept – This medication is administered through an injection and is used in combination with PET/CT imaging. It is currently being studied in clinical trials for its effectiveness in mapping sentinel lymph nodes in patients with high or high-intermediate risk endometrial cancer. The main therapeutic indication is to assist in the detection and staging of endometrial cancer by identifying lymph nodes that may contain cancer cells. At the molecular level, Gallium-68 Tilmanocept binds to receptors on the surface of immune cells in the lymph nodes, allowing for precise imaging. It is classified as a radiopharmaceutical agent used in diagnostic imaging.

Investigated diseases

Endometrial Cancer
This is a type of cancer that begins in the lining of the uterus, known as the endometrium. It is most commonly diagnosed in women who have gone through menopause. The disease often presents with abnormal vaginal bleeding, which prompts further investigation. As it progresses, the cancer can invade deeper layers of the uterus and may spread to nearby organs. Early detection is crucial as it typically starts in the inner lining and can be treated more effectively at this stage. The progression can vary, with some cases remaining localized while others may spread to lymph nodes or distant organs.
Uterine Cancer
This term generally refers to cancers that occur in the uterus, including endometrial cancer and other less common types like uterine sarcoma. Uterine cancer often presents with symptoms such as unusual vaginal bleeding or discharge, pelvic pain, or a mass. The disease can progress by invading the muscular layer of the uterus and potentially spreading to other parts of the body. It is most frequently diagnosed in postmenopausal women. The progression of uterine cancer can vary, with some types being more aggressive than others. Early detection and monitoring are important to manage the disease effectively.