RecruitingNAINTERVENTIONAL

Lymphatic Mapping Of Oropharyngeal Cancer

This study is looking at a new imaging and surgical method for people with throat cancer. When throat cancer spreads, it often goes to the lymph glands in the neck. Sometimes, it can spread to both sides of the neck, and deciding whether to treat both sides can be tricky. This new method uses a safe, low-dose tracer to light up the 'sentinel' lymph nodes – the first ones where cancer would spread. Doctors can then check these nodes during a standard examination. The goal is to provide more accurate information to help decide if treatment is needed on both sides of the neck, potentially avoiding unnecessary extensive treatment for some, and ensuring adequate treatment for others.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

150

Start

07 Jul 2022

Estimated completion

01 Jan 2027

Oropharyngeal Cancer

What is this study about?

When people are diagnosed with a type of throat cancer called oropharyngeal cancer, it often means the cancer has already spread to the small glands in the neck called lymph nodes. Treatment for this cancer involves tackling both the original tumour in the throat and any cancer in these lymph nodes. A common challenge is that this cancer can sometimes spread to lymph nodes on both sides of the neck, even if the main tumour is only on one side. Currently, doctors have to make an educated guess about whether to treat both sides, considering factors like how aggressive the cancer is and if the person smokes.

This guessing game means some people might have unnecessary treatment on both sides of their neck. This can lead to serious and long-lasting problems with swallowing, even requiring a feeding tube. On the flip side, some people only get treatment on one side, but then the cancer comes back on the other side. This study hopes to make this decision much clearer and more accurate. It's testing a special procedure called a sentinel node biopsy (SNB), which is a very precise way to find out if the cancer has spread to the other side of the neck.

The study involves two main steps for participants. First, a tiny, safe amount of a radioactive tracer will be injected near the tumour. This tracer quickly travels to the first lymph nodes that cancer would likely spread to – these are called 'sentinel' nodes. While you are already having a routine examination under anaesthetic, doctors will then use a special camera to find these glowing sentinel nodes. This allows them to examine these specific nodes for cancer spread with a high degree of accuracy, helping to guide treatment decisions.

Key takeaways

A study for people with newly diagnosed throat cancer.
Aims to improve decisions about treating lymph glands in the neck.
Uses a special tracer and camera to find 'sentinel' lymph nodes.
Could help avoid unnecessary treatment or improve cancer detection.
Procedure happens during a standard examination under anaesthetic.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or over. You must have a new diagnosis of oropharyngeal cancer – this includes all areas of the mouth and throat this cancer affects, and it doesn't matter if you have the Human Papilloma Virus (HPV) type of cancer or not. Your cancer should show that it has spread to lymph nodes on one side of your neck only, based on its specific classification.

There are some reasons why you wouldn't be able to join the study. These include if scans show you have suspicious signs of cancer in lymph nodes on both sides of your neck, or if you've already had radiotherapy or surgery to your neck. Also, if you have other types of throat cancer, or if the cancer has spread further to distant parts of your body like your lungs or bones, you wouldn't be eligible.

Additionally, pregnant or breastfeeding women cannot take part. You also need to be able to fully understand and agree to participate. Finally, if you have any known allergies to the tracer substances used in this type of imaging, you would not be able to join.

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 recently been diagnosed with oropharyngeal cancer?
Have scans shown cancer spread to lymph nodes on only one side of your neck?
Have you NOT had previous neck radiotherapy or surgery in that area?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main additional step involves an injection of a very small amount of a radioactive tracer substance during your routine examination under anaesthetic (EUA). This injection will be near your tumour. Afterwards, while you are still under anaesthetic, a special handheld camera will be used to detect where this tracer has gone, specifically identifying the 'sentinel' lymph nodes in your neck. This part of the procedure will be carried out at the same time as your planned EUA, so it won't require separate visits or a longer hospital stay for this stage. The follow-up from this procedure will then inform decisions about your future treatment.

Potential risks and benefits

Participating in this study might offer the benefit of more precise information about your cancer, potentially leading to more tailored and effective treatment decisions for you, and potentially avoiding unnecessary side effects from overtreatment or recurrence from undertreatment. The main risk involves a very small amount of radiation exposure from the tracer, which is considered safe and used routinely in medical imaging. There's also a tiny risk of an allergic reaction to the tracer, though this is rare. You are free to withdraw from the study at any time without it affecting your standard medical care.

Locations (2)

St George's University Hospitals NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
University College Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is oropharyngeal cancer?

It's a type of cancer that develops in the middle part of your throat, including the back of your tongue, soft palate, and tonsils.

What are lymph nodes?

These are small, bean-shaped glands that are part of your body's immune system, found throughout your body, including your neck. They help filter waste and fight infections.

What is a 'sentinel node'?

It's the very first lymph node that cancer cells would likely travel to if they spread from the original tumour.

Will this tracer make me radioactive?

The tracer contains a very small, safe dose of radioactivity that quickly leaves your body, similar to other standard imaging scans. You won't be 'radioactive' and it won't impact those around you.

Will taking part change my normal treatment?

The study aims to provide more information to guide your treatment decisions, but the additional procedure is done during your planned examination under anaesthetic and should not delay or change the overall plan for your care.

How to find out more

Trial Manager

ncita.looc@ucl.ac.uk 02076799274 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.