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Safety and Feasibility of Immuno-OCT (DETOUR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06008522
Recruitment Status : Not yet recruiting
First Posted : August 23, 2023
Last Update Posted : March 20, 2024
Sponsor:
Information provided by (Responsible Party):
University Medical Center Groningen

Study Description
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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
Colon Carcinoma Barrett Esophagus Gastrointestinal Dysplasia Drug: Bevacizumab-800CW Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 1, 2024
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arms and Interventions
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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 Name: OCT imaging


Outcome Measures
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Primary Outcome Measures :
  1. Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT [ Time Frame: during procedure ]
    Any events related to the device.


Secondary Outcome Measures :
  1. Validation of the immuno-OCT system: FME [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06008522


Contacts
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Contact: W.B. Nagengast, MD, PhD, PharmD +31503612620 w.b.nagengast@umcg.nl
Contact: Andrea Sterkenburg, MSc +316 55257029 a.j.sterkenburg@umcg.nl

Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: W.B. Nagengast, MD, PhD, PharmD University Medical Center Groningen
More Information
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Responsible Party: University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT06008522    
Other Study ID Numbers: 11258
First Posted: August 23, 2023    Key Record Dates
Last Update Posted: March 20, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Medical Center Groningen:
optical coherence tomography
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bevacizumab
 Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors