Safety and Feasibility of Immuno-OCT

Not Applicable

Not yet recruiting

• Conditions: Colon Carcinoma; Barrett Esophagus; Gastrointestinal Dysplasia
• Interventions: Drug: Bevacizumab-800CW

• Registration Number: NCT06008522
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-15
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-23
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-20
• Study Start: 2024-04-01
• Primary Completion: 2024-09-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Indication for a therapeutic endoscopy procedure (EMR or ESD);
• Age ≥ 18;
• Written informed consent.

Exclusion Criteria

• Patients younger than 18 years old;
• Submucosal and invasive esophageal adenocarcinoma (EAC) or colorectal carcinoma (CRC);
• Radiation therapy for esophageal or colorectal cancer;
• History of infusion reactions to Bevacizumab or other monoclonal antibodies;
• Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer;
• Non-adjustable hypertension;
• Medical or psychiatric conditions that compromise the patient's ability to give informed consent;
• Pregnancy or breastfeeding; a negative pregnancy test must be available for women of childbearing potential.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OCT with IV in colorectal polyps	Bevacizumab-800CW	OCT and FME imaging of Barret and colorectal lesions during endoscopy.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT	during procedure	Any events related to the device.

Secondary Outcome Measures

Name	Time	Method
Validation of OCT system: Ex vivo fluorescence imaging	During procedure	Validation of the immuno-OCT endoscopy results compared to the correlation of ex vivo fluorescent signals to histopathological analysis results.
validation of OCT system: ex vivo immuno-OCT imaging	During procedure	Validation of the immuno-OCT endoscopy results compared to the correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results.
Validation of the immuno-OCT system: FME	During procedure	Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results.
validation of OCT system: immunohistochemistry	Once, as soon as possible after procedure	Validation of the in vivo immune-OCT endoscopy results by comparing it to histopathological analysis results.