Safety and Feasibility of Immuno-OCT (DETOUR)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Barrett Esophagus; Colon Carcinoma; Gastrointestinal Dysplasia
• Intervention / Treatment: Drug: Bevacizumab-800CW

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: W.B. Nagengast, MD, PhD, PharmD; Phone Number: +31503612620; Email: w.b.nagengast@umcg.nl
• Study Contact Backup: Name: Andrea Sterkenburg, MSc; Phone Number: +316 55257029; Email: a.j.sterkenburg@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCT with IV in colorectal polyps; OCT and FME imaging of Barret and colorectal lesions during endoscopy.	Drug: Bevacizumab-800CW; Imaging of fluorescently labeled Bevacizumab-800CW using OCT.; Other Names: OCT imaging

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: W.B. Nagengast, MD, PhD, PharmD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: optical coherence tomography
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Bevacizumab
• Other Study ID Numbers: 11258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No