Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Optical PD-L1 imaging using Quantitative Fluorescence Endoscopy in locally advanced esophageal cancer using durvalumab-680LT: a phase I multicenter feasibility and safety study

This study is testing a new method called "optical PD-L1 imaging" for people with advanced oesophageal cancer. It involves using a special camera, called an endoscope, to look inside the gullet more closely. Before the endoscopy, participants will be given a small amount of a test drug, durvalumab-680LT, which helps highlight specific features of the cancer cells. This allows doctors to see more clearly if the cancer has certain markers that might respond to particular treatments. This is a very early-stage study (Phase I) to check if this new imaging method is safe and possible to do.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Universitair Medisch Centrum Groningen

Enrolment target

Start

21 Nov 2024

Esophageal cancer

What is this study about?

This study is looking at a new technique to help doctors understand oesophageal cancer, which is cancer of the gullet – the tube that carries food from your mouth to your stomach. The main goal is to see if a special type of imaging, called optical PD-L1 imaging, is safe and can be used in people.

PD-L1 is a specific marker that can be found on some cancer cells. Knowing if a cancer has this marker can help doctors decide if certain modern treatments, called immunotherapies, might be effective. Currently, we usually need to take a small piece of tissue (a biopsy) to check for this marker. This new method aims to find a less invasive way to see these markers directly inside the body using a special camera.

The study involves giving a very small, safe amount of a drug called durvalumab-680LT. This drug has a special tag that glows when seen with a particular camera during an endoscopy. By seeing where it glows, doctors hope to identify which cancer cells have the PD-L1 marker. This information could eventually lead to more personalised and effective treatments for people with oesophageal cancer.

Key takeaways

It's a study looking at a new way to image oesophageal cancer.
It uses a special camera and a small amount of a test drug.
The aim is to see specific markers on cancer cells more clearly.
This is a Phase I trial, meaning it's an early safety and feasibility study.
The information learned could lead to better-informed treatment choices in the future.

Who may be eligible?

This study is looking for adults who are at least 18 years old and have been diagnosed with oesophageal cancer that is considered locally advanced. "Locally advanced" means the cancer has grown into nearby tissues or lymph nodes but hasn't spread to distant parts of the body.

Both men and women can take part in this study. The medical team will check your full health history to make sure joining the study is safe and appropriate 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?
Do you have a diagnosis of oesophageal cancer?
Has your oesophageal cancer been described as 'locally advanced'?
Are you able to attend study appointments as required?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have a number of visits to the hospital. You will be given a small amount of the test drug, durvalumab-680LT, which is designed to help the special imaging work. You will then have an endoscopy procedure, where a thin, flexible tube with a camera is gently passed down your gullet to look at the cancer. The doctors will use special equipment during this endoscopy to see how the test drug interacts with your cancer cells. There will also be a follow-up period to check on your health after the main procedures. The total length of your involvement will be clearly explained by the study team.

Potential risks and benefits

Participating in this study might offer a potential benefit by providing doctors with more detailed information about your specific cancer, which could help in future treatment decisions. However, since this is a very early-stage study, the direct benefit to you might not be immediately clear. There are potential risks associated with any medical procedure or medication, such as discomfort during the endoscopy, or possible side effects from the investigational drug, though the study is designed to be as safe as possible. You are always free 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 oesophageal cancer?

Oesophageal cancer is a growth of unhealthy cells in the gullet, which is the food pipe connecting your mouth to your stomach.

What does 'locally advanced' mean?

It means the cancer has grown into nearby tissues or lymph nodes but has not spread to other distant parts of your body.

What is an endoscopy?

An endoscopy is a procedure where a doctor uses a thin, flexible tube with a camera on the end to look inside your body, in this case, your gullet.

What is PD-L1?

PD-L1 is a marker that can be found on some cancer cells. Finding it can help doctors predict if certain treatments might work well.

Will I receive treatment in this study?

This study is focused on improving imaging. While the information might help guide future treatment decisions, it's not a treatment study itself.