Safety and Feasibility of Immuno-OCT

NCT06008522 | Not Yet Recruiting

• 1 other identifier: 11258
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colon Carcinoma; Barrett Esophagus; Gastrointestinal Dysplasia

Keywords

optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Validation of the immuno-OCT system: FME

  During procedure

• Validation of OCT system: Ex vivo fluorescence imaging

  During procedure

• validation of OCT system: ex vivo immuno-OCT imaging

  During procedure

• validation of OCT system: immunohistochemistry

  Once, as soon as possible after procedure

Study Arms (1)

OCT with IV in colorectal polyps

EXPERIMENTAL

OCT and FME imaging of Barret and colorectal lesions during endoscopy.

Drug: Bevacizumab-800CW

Interventions

Bevacizumab-800CW DRUG

Imaging of fluorescently labeled Bevacizumab-800CW using OCT.

Also known as: OCT imaging

OCT with IV in colorectal polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead

MeSH Terms

Conditions

Colonic Neoplasms; Barrett Esophagus

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Precancerous Conditions; Esophageal Diseases

Study Officials

• W.B. Nagengast, MD, PhD, PharmD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

W.B. Nagengast, MD, PhD, PharmD

CONTACT

+31503612620; w.b.nagengast@umcg.nl

Andrea Sterkenburg, MSc

CONTACT

+316 55257029; a.j.sterkenburg@umcg.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: August 23, 2023
• Study Start: April 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: March 20, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share