Safety and Feasibility of Immuno-OCT

Study Overview
=================
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.

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

Conditions
-----------------
Colon Carcinoma, Barrett Esophagus, Gastrointestinal Dysplasia

Intervention / Treatment
-----------------
* Drug: Bevacizumab-800CW


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optical coherence tomography