Safety and Feasibility of Immuno-OCT

Sponsor
University Medical Center Groningen
Study ID
NCT06008522
Status
Unknown

Conditions

  • Barrett Esophagus
  • Colon Carcinoma
  • Gastrointestinal Dysplasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab-800CW — DRUG
    Imaging of fluorescently labeled Bevacizumab-800CW using OCT.

Study Details

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.

Key Dates

First listed
Aug 23, 2023
Start date
Apr 1, 2024
Status verified
Mar 2024
Primary completion
Sep 1, 2024
Completion
Mar 1, 2025

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: OCT with IV in colorectal polyps
    OCT and FME imaging of Barret and colorectal lesions during endoscopy.

Primary Outcome Measure

Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT [ Time Frame: during procedure ]

Central Contacts

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