Safety and Feasibility of Immuno-OCT

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Aug 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging system called immuno-OCT, designed to help doctors better detect early signs of abnormal tissue in the gastrointestinal tract, specifically in conditions like Barrett's esophagus and colon polyps. The goal is to improve the identification of premalignant lesions—tissue changes that could potentially lead to cancer—using a special fluorescent tracer linked to a well-known cancer treatment. This new technology might make it easier for doctors to see and target these lesions during endoscopic procedures, which are tests that allow doctors to look inside the body using a thin tube with a camera.

To participate in this trial, you need to be at least 18 years old and scheduled for a specific type of endoscopic procedure. It's important to note that there are certain conditions that would exclude someone from participating, such as having a recent cancer diagnosis or specific medical issues that could interfere with the study. If you qualify and choose to take part, you will help researchers test whether this advanced imaging system is safe and effective, which could lead to improved care for patients with gastrointestinal conditions in the future.

Gender

ALL

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.