Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

SENtinel lymph node mapping with GAllium-68-tilmanocept PET/CT in high/high- intermediate risk endometrial cancer: a proof-of-concept study

This research is investigating a new scanning method to help doctors find out if womb cancer (endometrial cancer) has spread to nearby lymph nodes. When cancer spreads, it often goes to these glands first. The study is particularly looking at patients with higher-risk types of womb cancer. The new method uses a special dye called Gallium-68-tilmanocept, which is injected into the body. Doctors then perform a PET/CT scan to see if the dye highlights any lymph nodes, which could indicate cancer spread. The main goal is to see how effectively this new scanning approach can identify these important 'sentinel' lymph nodes, which are the first nodes cancer cells would reach if they spread. This information helps doctors plan the best treatment.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

Start

15 Nov 2024

Endometrial cancer uterine cancer

What is this study about?

This study is about making sure patients with womb cancer get the most accurate information to help guide their treatment. When someone is diagnosed with womb cancer, it's very important for doctors to know if the cancer has spread beyond the womb. One of the first places cancer cells can go is to tiny glands called lymph nodes, located near the womb. Finding out if these 'sentinel' lymph nodes (the first ones cancer might reach) contain cancer cells is key for planning the right treatment.

Currently, there are ways to check these lymph nodes, but this research is testing a new method. It uses a special kind of dye, called Gallium-68-tilmanocept, which is injected into the body. This dye is designed to travel to the lymph nodes. After the dye is given, a special scan called a PET/CT is performed. Doctors will look at these scans to see if the dye lights up any lymph nodes, which would suggest they might contain cancer cells. The main goal is to see how successful this new PET/CT scan method is at finding these important lymph nodes compared to other techniques doctors might use during surgery.

By comparing this new scanning method with existing ones, the study hopes to find a more precise way to detect cancer spread to lymph nodes. This could lead to more tailored and effective treatment plans for patients with womb cancer, especially those with higher-risk forms of the disease. It's about giving doctors clearer information to make the best decisions for each patient.

Key takeaways

This study evaluates a new scan for womb cancer.
It aims to find out if cancer has spread to lymph nodes.
Uses a special dye and PET/CT scan.
For women with high-risk womb cancer.
Could help doctors plan better treatments.
Participation is voluntary and safe.

Who may be eligible?

This study is open to adult women who have been diagnosed with womb cancer. Specifically, it's for those with a type of womb cancer that doctors consider to be high or high-intermediate risk. This means the cancer might be more likely to spread, or it has certain features that make it more serious than other types of womb cancer.

To join, participants need to be at least 18 years old. As womb cancer affects women, the study is naturally for female patients. Other specific medical details will be checked by the study team to ensure it's safe and appropriate for you to take part.

Quick self-check

Are you an adult woman (18 years or older)?
Have you been diagnosed with womb cancer?
Has your doctor told you your womb cancer is considered 'high' or 'high-intermediate' risk?
Are you able to undergo a PET/CT scan?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would undergo a special procedure involving an injection of a small amount of a dye called Gallium-68-tilmanocept. This is followed by a PET/CT scan. This scan gives doctors detailed pictures of your body. The study team will measure how well this scan identifies lymph nodes. You will also have standard checks that are part of your usual care for womb cancer. We will also check for any side effects from the dye or scan in the first hour after the PET/CT. The full duration of your participation in the study would depend on your specific treatment plan, but the main intervention (injection and scan) is a one-off event. There will be follow-ups to compare the scan results with surgical findings and to see how your lymph nodes are doing over time.

Potential risks and benefits

Taking part in this study may offer the benefit of new and potentially more accurate information about your womb cancer, which could help your doctors plan your treatment more effectively. However, there's no guarantee that you will personally benefit directly. Potential risks include those associated with any injection, such as bruising or a slight discomfort. There's also a very small risk of reaction to the dye. The PET/CT scan involves exposure to a small amount of radiation, similar to other medical scans. You will be closely monitored for any reactions during the first hour after the scan. Please remember that participation is completely voluntary, and you are free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

—
Netherlands

Common questions

What is 'womb cancer'?

Womb cancer, also known as endometrial cancer, is a type of cancer that starts in the lining of the uterus (womb).

What are lymph nodes?

Lymph nodes are small, bean-shaped glands that are part of your body's immune system. They help filter waste and fight infections. Cancer cells can sometimes travel to these nodes.

What is a PET/CT scan?

A PET/CT scan is a type of imaging test that combines two different scans. It helps doctors see how your organs and tissues are working, and can show if there are any abnormal areas.

What is the 'dye' used in the study?

The dye is a special substance called Gallium-68-tilmanocept. It's designed to highlight lymph nodes on the PET/CT scan, helping doctors see them more clearly.

Will taking part in the study change my treatment?

The main goal of the study is to gather information about this new scanning method. The results might help doctors make more informed decisions about your treatment plan, but the study itself is focused on evaluating the scan. Your doctors will discuss all treatment options with you.