Ongoing Clinical Trials for Barrett’s Oesophagus
Currently, there are 3 clinical trials investigating new approaches for patients with Barrett’s oesophagus. These studies focus on preventing complications after treatment and improving early detection of abnormal tissue changes. The trials are being conducted across multiple European countries, testing both preventive medications and advanced imaging techniques.
Clinical trial locations
- France
- Germany
- Netherlands
- Study on Budesonide Tablets for Preventing Esophageal Narrowing in Adults After Cancer Tissue Removal
- Study on Detecting Early Barrett’s Esophagus Using Bevacizumab-800CW and Cetuximab-800CW for Patients with Barrett’s Esophagus
- Study on the Safety and Feasibility of Bevacizumab-800CW Imaging for Patients with Barrett’s Esophagus, Colon Cancer, or Gastrointestinal Dysplasia
- Poland
- Portugal
- Spain
- Sweden
Study on Budesonide Tablets for Preventing Esophageal Narrowing in Adults After Cancer Tissue Removal
This trial is testing whether budesonide, a medication that reduces inflammation, can prevent the development of esophageal strictures. These are narrowings of the esophagus that can occur after a procedure called endoscopic submucosal dissection, which is used to remove cancerous or pre-cancerous tissue.
Who can participate: Adults aged 18 to 85 years who have undergone endoscopic submucosal dissection for conditions such as esophageal squamous cell carcinoma or high-grade dysplasia are eligible. Participants must have a mucosal defect covering at least 50% to 75% of the esophagus, depending on their specific condition. They should have a life expectancy of at least one year and an ECOG Performance Status of 2 or less, which measures daily activity capability. Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control throughout the study.
Who cannot participate: Patients who have not undergone endoscopic submucosal dissection cannot join the study. Those unable to take the medication as prescribed, with medical conditions that might interfere with the study, or who are pregnant or breastfeeding are also excluded. Individuals participating in another clinical trial or those with a history of severe allergic reactions to budesonide cannot participate.
Study focus: The main goal is to determine how many participants remain free of esophageal strictures after eight weeks of treatment. The study will also track how many times participants need endoscopic dilation, a procedure to widen the esophagus if narrowing occurs. This is a double-blind trial, meaning neither participants nor doctors will know who receives the actual medication versus a placebo.
Investigational drug: Budesonide is provided as orodispersible tablets that dissolve in the mouth. Participants receive either a low dose of 2 x 1 mg per day or a high dose of 2 x 2 mg per day for eight weeks. Budesonide works as a corticosteroid, reducing inflammation by inhibiting the release of substances that cause swelling and irritation.
Study on Detecting Early Barrett’s Esophagus Using Bevacizumab-800CW and Cetuximab-800CW for Patients with Barrett’s Esophagus
This trial explores whether two specially modified medications, bevacizumab-800CW and cetuximab-800CW, can help doctors detect early cancerous changes in patients with Barrett’s oesophagus more effectively than standard methods. The medications are designed to light up abnormal areas when viewed with a special camera during endoscopy.
Who can participate: Adults with Barrett’s oesophagus are eligible, whether they have no dysplasia, low-grade dysplasia, high-grade dysplasia, or superficial esophageal adenocarcinoma. Participants must be planning to undergo a diagnostic or therapeutic endoscopy and must provide written informed consent after understanding the study details.
Who cannot participate: Individuals without Barrett’s oesophagus or those outside the specified adult age range cannot join. Vulnerable populations are also excluded from participation.
Study focus: The trial aims to determine whether using fluorescence molecular endoscopy with these specialized tracers makes it easier and quicker to identify early signs of cancer compared to standard high-definition white-light endoscopy. Researchers will assess both the effectiveness and safety of this new detection method.
Investigational drugs: Bevacizumab-800CW and cetuximab-800CW are given orally or applied topically. Bevacizumab-800CW targets proteins involved in blood vessel growth that supply tumors, while cetuximab-800CW binds to proteins on cancer cell surfaces. Both contain fluorescent components that make abnormal tissue visible under special imaging, helping doctors spot potential problem areas during the endoscopy procedure.
Study on the Safety and Feasibility of Bevacizumab-800CW Imaging for Patients with Barrett’s Esophagus, Colon Cancer, or Gastrointestinal Dysplasia
This trial investigates a new imaging technique called immuno-OCT that combines structural imaging with fluorescence to provide detailed pictures of the digestive tract. The study uses bevacizumab-800CW with a swallowable capsule-based imaging device to capture high-resolution images.
Who can participate: Adults aged 18 years or older who have an indication for therapeutic endoscopy procedures such as endoscopic mucosal resection or endoscopic submucosal dissection can participate. These procedures are used to remove abnormal tissue from the digestive tract. Participants must provide written informed consent after being fully informed about the study.
Who cannot participate: The study excludes patients with a history of Barrett’s oesophagus, those diagnosed with colon carcinoma, and individuals with gastrointestinal dysplasia.
Study focus: The primary objectives are to evaluate the safety of the immuno-OCT imaging procedure by monitoring for any device-related side effects, and to assess whether this imaging method is practical for clinical use. Results will be compared to other imaging techniques and tissue analysis to validate effectiveness.
Investigational drug: Bevacizumab-800CW combines the medication bevacizumab, which blocks blood vessel growth that feeds tumors, with a fluorescent dye. This combination is administered intravenously and helps doctors visualize tissues more clearly during imaging tests. The fluorescent component lights up when viewed with a special camera, allowing better understanding of what is happening in the examined tissues.
Summary
The three ongoing clinical trials for Barrett’s oesophagus reflect two distinct research priorities: prevention of complications after treatment and improvement of early cancer detection methods.
The budesonide trial represents a multi-country European effort, recruiting across seven nations including Germany, Sweden, Netherlands, Poland, Spain, Portugal, and France. This geographic spread suggests broad interest in addressing esophageal strictures, a common complication following tissue removal procedures.
The Netherlands appears to be a focal point for advanced imaging research, hosting both trials investigating bevacizumab-800CW technology. These studies represent innovative approaches to early detection, utilizing fluorescent tracers to highlight abnormal tissue that might otherwise be missed during standard examinations.
A notable distinction exists between the trials: while the budesonide study focuses on preventing physical complications in patients who have already undergone treatment, the imaging trials target earlier intervention by improving detection capabilities. This dual approach addresses both treatment aftermath and proactive monitoring, reflecting the comprehensive nature of current research efforts for this condition.
