Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

SLURP; A phase 2 intervention study: Detection of early esophageal neoplastic lesions by quantified fluorescence molecular endoscopy using oral and topical administration of bevacizumab-800CW and cetuximab-800CW

This research, called SLURP, is for people with Barrett's oesophagus who are at risk of developing problems in their food pipe. Doctors want to see if giving special glowing liquids by mouth can make it easier to spot early signs of disease during a camera test of the food pipe (a common procedure). These liquids contain medicines similar to ones already used for other conditions, but here they're used to help light up any suspicious areas. The study aims to check if this method is safe, can be done successfully, and if it improves how well doctors can find these early changes compared to standard methods. It's a Phase 2 study, meaning it's exploring whether this new approach is promising and safe enough for further testing.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Medical Center Groningen

Enrolment target

Start

22 May 2023

Barrett's esophagus

What is this study about?

This study, called SLURP, is for people who have a condition called Barrett's oesophagus. This condition means that the lining of your food pipe (the tube that food goes down) has changed. These changes can sometimes, over many years, lead to more serious problems if not monitored closely. The main goal of this study is to find better ways to spot these early changes before they become a bigger issue.

Currently, doctors look for these changes using a camera test (an endoscopy). This study wants to see if using a special technique, where glowing liquids are given by mouth, can make it easier for them to see problematic areas during this camera test. The liquids used are based on existing medicines but are specially prepared to 'light up' certain cells that might be changing. By making these areas glow, doctors hope to identify them more clearly and earlier.

The study is trying to understand two key things: first, if it's safe and practical to give these glowing liquids by mouth. Second, if using a combination of these liquids actually helps doctors find more early problem spots than they would without them. This could potentially lead to earlier detection and better management for people with Barrett's oesophagus.

Key takeaways

This study explores a new way to detect early tissue changes in Barrett's oesophagus.
It uses special glowing liquids, taken by mouth, during a camera examination (endoscopy).
The main goals are to check if this method is safe, practical, and improves detection.
Participants must have a diagnosis of Barrett's oesophagus.
You can stop participating at any time.
This is a Phase 2 study, meaning it's an early-stage investigation of a promising new approach.

Who may be eligible?

This study is designed for adults aged 18 years and older, with no upper age limit. Both men and women are welcome to participate.

To be eligible, you must have a confirmed diagnosis of Barrett's oesophagus. This condition means you have specific changes in the lining of your food pipe that doctors monitor. The research is particularly interested in those who might be at risk of developing more serious changes.

There might be other specific health conditions or medications that would prevent someone from joining the study, but the main criteria are being an adult with Barrett's oesophagus.

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 Barrett's oesophagus?
Are you able to attend study visits, including an endoscopy?
Do you understand that you will be given special liquids by mouth?
Are you comfortable with the possibility of having a biopsy during the endoscopy?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a screening visit to check if you're suitable. Once confirmed, you would likely have one or more study visits, which would involve undergoing an endoscopy. This is a common procedure where a thin, flexible tube with a camera is passed down your throat to look at your food pipe.

During this endoscopy, you would receive the special glowing liquids by mouth before the procedure or possibly during it. The doctors would then use a special camera to look for areas that 'light up'. They would also take small tissue samples (biopsies), which is standard practice during an endoscopy, to examine them more closely under a microscope.

There might be follow-up appointments to check on your health and any effects of the liquids. The total duration of your participation in the study would depend on the specific schedule, but the main intervention involves the endoscopy and observation of the liquids' effects.

Potential risks and benefits

Participating in any research study has potential benefits and risks. A potential benefit of this study is that the new technique might help doctors find early changes in your food pipe more effectively, which could lead to earlier treatment if needed. However, it's important to remember this is a research study, and there's no guarantee of direct benefit to you. Potential risks might include those commonly associated with an endoscopy itself, such as discomfort, a sore throat, or very rarely, more serious complications. There could also be side effects from the special liquids, though they are based on existing medications and the study aims to assess their safety. You can ask the study team about all potential risks and benefits. Importantly, you are always free to withdraw from the study at any time, for any reason, without 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 Barrett's oesophagus?

It's a condition where the lining of your food pipe changes, usually due to acid reflux. These changes need to be monitored by doctors.

What exactly are the 'glowing liquids'?

These are special liquids based on existing medicines, but they contain a dye that makes certain cells in your food pipe light up under a special camera during an endoscopy. This helps doctors see them better.

Will I feel the liquids working or see anything glowing myself?

No, you shouldn't feel them glow. The glowing effect is only visible with special equipment used by the doctors during the camera test.

Is an endoscopy painful?

Most people find endoscopy uncomfortable rather than painful. You'll usually be offered sedation to help you relax during the procedure.

What happens after the study?

After your participation, you'll return to your usual medical care. The results of the study will help researchers understand if this new method is useful for detecting problems in Barrett's oesophagus patients.