AuthorisedTherapeutic exploratory (Phase II)Interventional

REFLECT; Real-time targeted fluorescence endoscopy for detection of the primary cancer lesion in patients with a metastasis of unknown primary tumor in the head and neck

This study, called REFLECT, is testing a new approach to find the original tumour in people who have head and neck cancer that has spread to their lymph nodes, but the main cancer site hasn't been found. This type of cancer spread is called a 'metastasis of unknown primary'. Doctors will use a special endoscopy technique that makes cancer cells glow with the help of a drug called Erbitux. The study wants to see how well this new method works compared to standard endoscopy in highlighting the main cancer. It will also look at how the drug spreads and how this glowing effect helps doctors find the cancer. The aim is to improve how doctors detect these hidden cancers, which could lead to better treatment plans.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

08 Nov 2024

Unknown primary tumour of the head and neck

What is this study about?

When someone has a lump in their neck that turns out to be cancer, but doctors can't immediately find where that cancer started, it's called a 'metastasis of unknown primary' in the head and neck. Finding this original cancer (the primary tumour) is very important because it helps doctors choose the best treatment. However, sometimes these primary tumours are very small or hidden, making them hard to spot with usual examination methods.

This study, called REFLECT, is trying out a new way to find these hidden cancers. It involves using a special type of light-based scanning during an endoscopy procedure. During the endoscopy, you'll receive a drug called Erbitux. This drug has a special substance in it that can make cancer cells glow when using a special camera. The doctors will then look to see if they can spot the primary cancer more easily with this glowing effect compared to just looking with a regular endoscopy camera.

The main goal of this study is to see how well this new glowing endoscopy technique works at finding the original cancer and how the special glowing substance spreads in the body. They will compare these findings to standard endoscopy. The study will also collect information about participants' health, how they feel, and look at tissue samples to understand more about the cancers. This research could help doctors improve how they find and treat these difficult-to-locate head and neck cancers in the future.

Key takeaways

This study is for people with head and neck cancer where the original site hasn't been found.
It uses a new glowing endoscopy technique to help locate hidden cancers.
A drug called Erbitux helps make cancer cells visible during the procedure.
The goal is to improve how doctors find these challenging cancers.
Participation involves an endoscopy and receiving the study drug.
You'll complete questionnaires about your health and quality of life.

Who may be eligible?

To join this study, you need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

You would be considered for this study if you have been diagnosed with a cancer in your head or neck that has spread to your lymph nodes, but doctors haven't yet been able to find where the cancer originally started.

There might be other health reasons that could mean this study isn't right for you, or certain medications you're taking could exclude you. The study team will review your full medical history to make sure it's safe and appropriate for you to participate.

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 cancer in your head or neck that has spread?
Have doctors not yet found the original place where your cancer started?
Are you willing to receive a study drug (Erbitux) through a drip?
Are you able to have an endoscopy procedure?

Answer every question to see your result.

What does participation involve?

If you decide to join the REFLECT study, you will undergo a special endoscopy procedure. Before this, you'll receive a dose of the study drug, Erbitux, through a drip. During the endoscopy, doctors will use both standard vision and special 'fluorescence' cameras to look for the original cancer. This involves carefully looking at the inside of your throat and voice box.

Throughout the study, the research team will monitor your general health, including your age, sex, weight, and any other health conditions you have had. They will also take tissue samples if they find suspicious areas. You'll also be asked to fill out questionnaires about your quality of life, focusing on general health, head and neck symptoms, and your ability to swallow. The exact number of visits and follow-up will be explained by the study team, but it will involve assessments before and after receiving the drug and the endoscopy procedure.

Potential risks and benefits

Participating in this study might offer a potential benefit of helping doctors find your original cancer more effectively than standard methods, which could lead to a more targeted treatment plan for you. However, it's important to remember that this is a research study, and there's no guarantee it will directly benefit your health. As with any medical procedure or medication, there are potential risks, including side effects from the Erbitux drug or risks associated with the endoscopy procedure itself. These will be fully explained to you by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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 an 'unknown primary' cancer?

It means cancer has spread, usually to a lymph node, but doctors can't find where the cancer originally started in the body.

What is Erbitux?

Erbitux is a medication that, in this study, helps make cancer cells glow when viewed with a special camera during endoscopy.

What is endoscopy?

Endoscopy is a procedure where a doctor uses a thin, flexible tube with a camera to look inside your body, in this case, your throat and voice box.

Will this study definitely find my cancer?

This is a research study testing a new method. While it aims to improve detection, there's no guarantee it will find your specific cancer.

Will I have to pay to be in the study?

No, you will not have to pay to participate in the study. All study-related procedures and drugs are provided free of charge.