Safety and feasibility of immuno-OCT
Phase 1
Recruiting
- Conditions
- Barrett's esophagus, Colon carcinoma, gastrointestinal dysplasiaTherapeutic area: Diseases [C] - Neoplasms [C04]Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2023-506395-27-00
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Indication for a therapeutic endoscopy procedure (EMR or ESD), Age = 18, Written informed consent
Exclusion Criteria
Submucosal and invasive EAC or 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 breast feeding; a negative pregnancy test must be available for women of childbearing potential
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Determine safety and feasibility of immuno-OCT in vivo imaging with the tracer Bevacizumab-800CW;Secondary Objective: Validate the immuno-OCT endoscopy system based on Immunohistochemistry., Validate the immuno-OCT endoscopy system based on Fluorescence molecular endoscopy., Validate the immuno-OCT endoscopy system based on Ex vivo immuno-OCT imaging, Validate the immuno-OCT endoscopy system based on Ex vivo fluorescence imaging;Primary end point(s): Safety evaluation of immuno-OCT imaging: Number of adverse device-related events (ADE’s) and serious adverse device-related events (SADE’s)., Feasibility of in vivo immuno-OCT imaging and interpretation of the in vivo immuno-OCT results
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Validation of the immuno-OCT endoscopy results compared to: Fluorescence seen in FME imaging results; The correlation of ex vivo fluorescent signals to histopathological analysis results; The correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis results;