Authorised (with conditions)Phase III and phase IV (Integrated)Interventional

Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CT.

This research is investigating a new scanning method to detect if oral cancer has spread to lymph nodes, which are small, bean-shaped glands that help fight infection. The study is called 'Sentinel lymph node (SLN) detection in early oral cancer using Gallium-68-Tilmanocept PET/CT'. It's comparing a new PET/CT scan that uses a substance called Gallium-68-Tilmanocept with current methods, like standard lymphoscintigraphy. The main goal is to see how good this new scan is at finding these lymph nodes and predicting if cancer cells are present, helping doctors make the best treatment decisions for people with early oral cancer. This research is in advanced stages, combining Phase III and Phase IV studies.

At a glance

Status

Authorised (with conditions)

Phase

Phase III and phase IV (Integrated)

Sponsor

Universitair Medisch Centrum Utrecht

Enrolment target

Start

18 Apr 2025

Oral cancer

What is this study about?

This study is designed to help doctors better understand if oral cancer has spread to nearby lymph nodes. When cancer starts to spread, it often first goes to the 'sentinel lymph node' – the first lymph node that drains fluid from the area where the cancer is. If this node is clear of cancer, it's a good sign that the cancer hasn't spread further.

Currently, doctors use a technique called lymphoscintigraphy, which involves injecting a tiny amount of a radioactive substance (Technetium) and using a special camera to track its path to the lymph nodes. This study is exploring a new approach using a substance called Gallium-68-Tilmanocept with a PET/CT scan. The aim is to see if this new scan is more accurate or as good as the current method in finding these important lymph nodes and determining if cancer cells are present. The information gained from this study could improve how doctors decide on the best treatment for people with oral cancer.

The study also aims to compare how many lymph nodes are found by each method, and how well each method matches what doctors find when they look at the lymph nodes under a microscope. Researchers will also look at how drainage patterns differ and if different doctors interpret the scans similarly.

Key takeaways

Tests a new scan for oral cancer spread to lymph nodes.
Compares it to existing methods for accuracy.
Aims to improve treatment decisions for oral cancer.
Involves special scans and possibly lymph node removal.
Open to adults with early oral cancer (18+).

Who may be eligible?

To take part in this study, you must be at least 18 years old. Both men and women are welcome to participate.

This study is specifically for individuals who have been diagnosed with early oral cancer. Oral cancer affects the mouth, including the lips, tongue, gums, and other areas inside the mouth.

There might be other specific criteria, such as the exact type and stage of your oral cancer, or other health conditions you might have, that would need to be considered by the study doctors. They would discuss all of this with you to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with early oral cancer?
Are you able to attend appointments for scans?
Do you understand what taking part might involve?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would likely undergo specific medical procedures related to the diagnostic scans. This would involve receiving injections of the special substances (Gallium-68-Tilmanocept and Technetium-99m) before scans like PET/CT and lymphoscintigraphy.

There might be visits to the hospital or clinic for these scans and follow-up appointments. The exact number of visits and the total duration of your participation would be explained in detail by the study team. They would also explain if any further procedures, such as surgical removal of lymph nodes, are part of the process, and when these would happen.

Potential risks and benefits

Taking part in a study like this might offer the potential benefit of contributing to new knowledge that could improve future care for people with oral cancer. You might also receive careful monitoring of your condition. However, there are potential risks, such as side effects from the injected substances (like a mild allergic reaction) or from the radiation exposure, though the levels are kept as low as possible. There's also the chance the new scan method might not be more accurate than current methods. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is the main goal of this study?

The main goal is to see if a new type of scan can better detect if oral cancer has spread to lymph nodes compared to current methods.

What is a 'sentinel lymph node'?

It's the first lymph node that cancer cells are likely to reach if the cancer starts to spread from the original tumour.

What is a PET/CT scan?

It's a type of imaging scan that combines a PET scan (which shows how your body's cells are working) and a CT scan (which shows detailed pictures of your bones and soft tissues) to give a very detailed view.

Will I have to have an operation if I join the study?

The study aims to compare imaging methods, but if lymph nodes are identified, their removal for analysis is a standard part of cancer care, which your doctors would discuss with you.

Who can take part in this study?

Adults (18 years or older) with early oral cancer can take part. Both men and women are included.