Study on the Safety and Feasibility of Bevacizumab-800CW Imaging for Patients with Barrett’s Esophagus, Colon Cancer, or Gastrointestinal Dysplasia

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What is this study about?

This clinical trial is focused on studying the safety and practicality of a new imaging technique called immuno-OCT for certain conditions affecting the digestive system. The diseases being studied include Barrett’s esophagus, colon cancer, and gastrointestinal dysplasia. The treatment involves using a special tracer called Bevacizumab-800CW, which is a modified form of the medication Avastin. This tracer is used in combination with a capsule-based imaging device that patients swallow, allowing doctors to capture detailed images of the gastrointestinal tract.

The purpose of the study is to determine if this new imaging method is safe and can be effectively used in patients. During the study, participants will undergo a procedure where the capsule is swallowed and then manually retrieved, capturing high-resolution images of the digestive tract. This imaging technique combines structural imaging with a special type of imaging called near-infrared fluorescence, which helps visualize specific areas of interest, such as potential tumor sites or areas of inflammation.

The study will monitor the safety of the immuno-OCT imaging by tracking any device-related side effects. It will also assess how well the imaging method works in practice. The results from this imaging will be compared to other imaging techniques and tissue analysis to validate its effectiveness. The study is expected to continue until early 2025, with recruitment starting in December 2023.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are 18 years or older and have an indication for a therapeutic endoscopy procedure, such as EMR (endoscopic mucosal resection) or ESD (endoscopic submucosal dissection).

3 medication administration

You will receive a medication called Avastin 25 mg/ml concentrate for solution for infusion. This medication contains the active substance bevacizumab and will be administered through an intravenous infusion. The specific dosage, frequency, and duration will be determined by the study team based on the study protocol.

4 imaging procedure

The study involves a procedure called immuno-OCT (optical coherence tomography). This imaging technique will be used to capture detailed images of your tissues. The goal is to determine the safety and feasibility of this imaging method.

5 safety evaluation

Throughout the study, there will be a focus on evaluating the safety of the imaging procedure. This includes monitoring for any adverse device-related events (ADEs) or serious adverse device-related events (SADEs).

6 feasibility assessment

The study will also assess the feasibility of using the immuno-OCT imaging technique. This involves interpreting the results obtained from the imaging process.

7 comparison and validation

The results from the immuno-OCT imaging will be compared to other imaging results, such as fluorescence seen in FME (fluorescence molecular endoscopy) imaging. Additionally, the study will validate these results by comparing them to histopathological analysis, which involves examining tissues under a microscope.

8 completion of study

The study is expected to be completed by January 2, 2025. You will be informed about the outcomes and any relevant findings related to your participation.

Who Can Join the Study?

The patient must have a reason to undergo a therapeutic endoscopy procedure. This could be either an EMR (Endoscopic Mucosal Resection) or ESD (Endoscopic Submucosal Dissection). These are procedures used to remove abnormal tissue from the digestive tract.
The patient must be at least 18 years old.
The patient must provide written informed consent. This means the patient agrees to participate in the study after being fully informed about the study’s details and risks.

Who Cannot Join the Study?

Patients with a history of Barrett’s esophagus cannot participate.
Patients diagnosed with colon carcinoma are not eligible.
Individuals with gastrointestinal dysplasia are excluded from the study.

Where you can join this trial?

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Site Name	City	Country	Status
Uniedkjrmxxk Mmsscnt Cxcjrwl Guewbihsb	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Bevacizumab

Bevacizumab-800CW is a special type of medication used in this clinical trial. It is a combination of a drug called Bevacizumab and a fluorescent dye. Bevacizumab is a medication that can attach to certain proteins in the body, and it is often used to treat various types of cancer by stopping the growth of blood vessels that feed tumors. In this trial, Bevacizumab is linked to a dye that lights up when viewed with a special camera. This helps doctors see inside the body more clearly during imaging tests, allowing them to better understand what is happening in the tissues being studied. The main goal of using this combination is to check if it is safe and if it works well for imaging purposes.

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 and may lead to further complications. The progression involves the replacement of normal esophageal cells with abnormal cells, known as intestinal metaplasia. This condition can remain stable for years, but in some cases, it may progress to more severe forms of dysplasia. Monitoring is essential to observe any changes in the tissue over time.

Colon carcinoma – Colon carcinoma, also known as colorectal cancer, begins in the colon or rectum. It typically starts as a growth called a polyp on the inner lining of the colon or rectum. Over time, some polyps can develop into cancer. The progression involves the growth of cancerous cells that can invade deeper layers of the colon wall. As the disease advances, it may spread to nearby lymph nodes and other parts of the body. The development from a benign polyp to carcinoma can take several years.

Gastrointestinal dysplasia – Gastrointestinal dysplasia refers to the presence of abnormal cells in the lining of the gastrointestinal tract. These changes are considered precancerous, meaning they have the potential to develop into cancer over time. Dysplasia is often categorized as low-grade or high-grade, depending on the extent of abnormal cell changes. The progression involves the accumulation of genetic mutations that can lead to more severe cellular abnormalities. High-grade dysplasia is more likely to progress to cancer if left untreated. Regular monitoring is crucial to detect any progression towards malignancy.

Trial ID:

2023-506395-27-00

NCT ID:

NCT06008522

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Feasibility of Bevacizumab-800CW Imaging for Patients with Barrett’s Esophagus, Colon Cancer, or Gastrointestinal Dysplasia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?