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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCT with IV in colorectal polyps | Experimental | OCT and FME imaging of Barret and colorectal lesions during endoscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab-800CW | Drug | Imaging of fluorescently labeled Bevacizumab-800CW using OCT. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Device-related Events (ADEs) and Serious Adverse Device-related Events (SADEs) using immuno-OCT | Any events related to the device. | during procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Validation of the immuno-OCT system: FME | Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results. | During procedure |
| Validation of OCT system: Ex vivo fluorescence imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| W.B. Nagengast, MD, PhD, PharmD | Contact | +31503612620 | w.b.nagengast@umcg.nl | |
| Andrea Sterkenburg, MSc | Contact | +316 55257029 | a.j.sterkenburg@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| W.B. Nagengast, MD, PhD, PharmD | University Medical Center Groningen | Principal Investigator |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Validation of the immuno-OCT endoscopy results compared to the correlation of ex vivo fluorescent signals to histopathological analysis results.
| During procedure |
| validation of OCT system: ex vivo immuno-OCT imaging | Validation of the immuno-OCT endoscopy results compared to the correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results. | During procedure |
| validation of OCT system: immunohistochemistry | Validation of the in vivo immune-OCT endoscopy results by comparing it to histopathological analysis results. | Once, as soon as possible after procedure |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011230 | Precancerous Conditions |
| D004935 | Esophageal Diseases |