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DETOUR: Safety and Feasibility of Immuno-OCT

Sponsor
University Medical Center Groningen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06008522
Collaborator
(none)
15
Enrollment
1
Arm
12
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Determining the Safety and Feasibility of Optical Coherence Tomography and Near Infrared Fluorescence: a Prospective Pilot Intervention Study
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
May 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

      Any events related to the device.

    Secondary Outcome Measures

    1. Validation of the immuno-OCT system: FME [During procedure]

      Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results.

    2. Validation of OCT system: Ex vivo fluorescence imaging [During procedure]

      Validation of the immuno-OCT endoscopy results compared to the correlation of ex vivo fluorescent signals to histopathological analysis results.

    3. validation of OCT system: ex vivo immuno-OCT imaging [During procedure]

      Validation of the immuno-OCT endoscopy results compared to the correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results.

    4. validation of OCT system: immunohistochemistry [Once, as soon as possible after procedure]

      Validation of the in vivo immune-OCT endoscopy results by comparing it to histopathological analysis results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    dr. W.B. Nagengast, MD, Prof. dr. W.B. Nagengast, University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT06008522
    Other Study ID Numbers:
    • 11258
    First Posted:
    Aug 23, 2023
    Last Update Posted:
    Aug 23, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by dr. W.B. Nagengast, MD, Prof. dr. W.B. Nagengast, University Medical Center Groningen
    optical coherence tomography
    Additional relevant MeSH terms:
    Barrett Esophagus
    Bevacizumab

    Study Results

    No Results Posted as of Aug 23, 2023