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Trial Title:
Safety and Feasibility of Immuno-OCT
NCT ID:
NCT06008522
Condition:
Colon Carcinoma
Barrett Esophagus
Gastrointestinal Dysplasia
Conditions: Official terms:
Barrett Esophagus
Bevacizumab
Conditions: Keywords:
optical coherence tomography
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Bevacizumab-800CW
Description:
Imaging of fluorescently labeled Bevacizumab-800CW using OCT.
Arm group label:
OCT with IV in colorectal polyps
Other name:
OCT imaging
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
March 1, 2025
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06008522
