Barrett Esophagus, Colon Carcinoma, Gastrointestinal Dysplasia
Conditions
Keywords
optical coherence tomography
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.
Interventions
Imaging of fluorescently labeled Bevacizumab-800CW using OCT.
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Validation of the immuno-OCT system: FME | During procedure | Validation of the immuno-OCT endoscopy results compared to fluorescence seen in FME imaging results. |
| 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. |
| 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. |
| 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. |
Contacts
Primary ContactW.B. Nagengast, MD, PhD, PharmD
Backup ContactAndrea Sterkenburg, MSc
Outcome results
None listed