NCT06008522

Safety and Feasibility of Immuno-OCT

Determining the Safety and Feasibility of Optical Coherence Tomography and Near Infrared Fluorescence: a Prospective Pilot Intervention Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: University Medical Center Groningen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To improve detection of premalignant lesions in the gastrointestinal tract (the rectum and the esophagus) there is a need for better endoscopic visualization and the ability for targeted biopsies. The University Medical Center Groningen (UMCG) developed a fluorescent tracer by labelling the VEGF-A-targeting humanized monoclonal antibody bevacizumab, currently used in anti-cancer therapy, with the fluorescent dye bevacizumab-800CW (IRDye800CW). In several phase I studies and phase II studies, either completed or currently running, in the UMCG, the use of VEGF-A-guided near-infrared (NIR) fluorescence molecular endoscopy (FME) in combination with high-definition white light endoscopy (HD-WLE) shows an improved detection rate of early premalignant lesions. In this study the safety and feasibility of a next generation imaging system will be tested. This system uses immune optical coherence tomography (immuno-OCT) and near infrared fluorescence (NIRF) with the targeted tracer (Bevacizumab-800CW) for improvement of the detection of dysplastic lesions in Barret's esophagus (BE) and colorectal polyp detection. The system provides more depth information and can eventually be used without the guidance of the regular endoscopy system.

Conditions

• Colon Carcinoma
• Barrett Esophagus
• Gastrointestinal Dysplasia

Interventions

Type	Name	Description
DRUG	Bevacizumab-800CW	Imaging of fluorescently labeled Bevacizumab-800CW using OCT.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-09-01
• Completion: 2025-03-01
• First posted: 2023-08-23
• Last updated: 2024-03-20