Study on Detecting Early Barrett’s Esophagus Using Bevacizumab-800CW and Cetuximab-800CW for Patients with Barrett’s Esophagus

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What is this study about?

This clinical trial is focused on studying a condition known as Barrett’s esophagus, which can sometimes lead to a type of cancer in the esophagus. The study is testing two treatments, bevacizumab and cetuximab, which are given in a special form that allows them to be seen using a technique called fluorescence molecular endoscopy. This technique helps doctors see early changes in the esophagus that might not be visible with regular methods.

The purpose of the study is to see if using these treatments can help detect early signs of cancer in patients with Barrett’s esophagus more effectively than the usual method, which is called high-definition white-light endoscopy. The study will involve giving the treatments by mouth and then using the special endoscopy to look for changes in the esophagus. The researchers want to find out if this method can make it easier and quicker to spot any early signs of cancer.

Participants in the study will receive either the treatments or a placebo, and the researchers will compare the results to see if the new method is better at finding early signs of cancer. The study will also look at the safety of using these treatments in this way. The goal is to improve how early esophageal cancer is detected, which could lead to better outcomes for patients with Barrett’s esophagus.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This is a document that confirms your understanding of the study and your willingness to participate.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have Barrett’s esophagus without dysplasia or with suspected/diagnosed low-grade dysplasia, high-grade dysplasia, or superficial esophageal adenocarcinoma.

A planned diagnostic and/or therapeutic endoscopy will be scheduled as part of this assessment.

3 medication administration

You will receive oral administration of two medications: bevacizumab-800CW and cetuximab-800CW. These are given as solutions for infusion, which means they are administered in liquid form.

The purpose of these medications is to help detect early esophageal lesions using a special type of endoscopy called quantified fluorescence molecular endoscopy (qFME).

4 endoscopy procedure

You will undergo a qFME procedure. This is a type of endoscopy that uses fluorescent tracers to help identify abnormal areas in the esophagus.

The procedure aims to detect neoplasia, which are early signs of cancer, in patients with Barrett’s esophagus.

5 follow-up and monitoring

After the endoscopy, you will be monitored for any side effects or reactions to the medications.

The study will collect data on the safety and effectiveness of the oral tracer administration.

6 completion of study participation

Your participation in the study will conclude after the follow-up period. The study is expected to end by December 31, 2024.

The information gathered will contribute to understanding the feasibility and safety of using these medications for early detection of esophageal lesions.

Who Can Join the Study?

Patients must have Barrett’s esophagus, which is a condition where the lining of the esophagus changes.
Patients can participate if they do not have dysplasia (abnormal cells) or if they have been diagnosed with low-grade dysplasia (LGD), high-grade dysplasia (HGD), or superficial esophageal adenocarcinoma (EAC).
Patients should be planning to have a diagnostic or therapeutic endoscopy, which is a procedure where a doctor uses a flexible tube with a camera to look inside the esophagus.
Patients must provide written informed consent, meaning they agree to participate in the study after being fully informed about it.
Both men and women can participate in the study.
Participants should be adults, as the study includes age ranges typically for adults.

Who Cannot Join the Study?

Patients who do not have Barrett’s esophagus cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ulzxohjtoace Miepjfs Cyeifwi Gudugcvej	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not recruiting	01.05.2023

Trial locations

Investigated drugs:

Bevacizumab-800CW is a special version of a medication that is used to help doctors see certain areas inside the body more clearly during an examination. In this study, it is used to help detect early signs of cancer in the esophagus. The medication is given to patients either by mouth or applied directly to the area being examined. It works by attaching to specific parts of the body that might be affected by cancer, and then it lights up under a special camera, making it easier for doctors to spot any problems.

Cetuximab-800CW is another special version of a medication used in this study to help doctors find early signs of cancer in the esophagus. Like bevacizumab-800CW, it is used to make certain areas inside the body more visible during an examination. This medication is also given to patients either by mouth or applied directly to the area being examined. It attaches to specific parts of the body that might be affected by cancer and lights up under a special camera, helping doctors to detect any issues more easily.

Investigated diseases:

Barrett's oesophagus

Barrett’s esophagus – Barrett’s esophagus is a condition where the tissue lining the esophagus changes to resemble the lining of the intestine. This change is often due to chronic acid exposure from gastroesophageal reflux disease (GERD). Over time, the altered cells can become more pronounced, leading to a condition known as dysplasia, which is a precancerous state. The progression of Barrett’s esophagus can vary, with some individuals experiencing a slow progression while others may see more rapid changes. The condition itself does not cause symptoms, but it is associated with GERD symptoms like heartburn. Regular monitoring is important to detect any progression towards esophageal cancer.

Trial ID:

2023-503801-12-00

Protocol code:

16054

NCT ID:

NCT05745857

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Detecting Early Barrett’s Esophagus Using Bevacizumab-800CW and Cetuximab-800CW for Patients with Barrett’s Esophagus

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?