Determining the safety and feasibility of optical coherence tomography and near infrared fluorescence: a prospective pilot intervention study
- Conditions
- Barret's esophaguscoloncarcinomadysplasia10017991
- Registration Number
- NL-OMON56591
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 15
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 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Safety:<br /><br>o Number of Adverse Device-related Events (ADEs) and Serious Adverse<br /><br>Device-related Events (SADEs).<br /><br>- Feasibility:<br /><br>o Feasibility to acquire images with the immuno-OCT endoscope and to interpret<br /><br>the resulting images and results. This will not be statistical analyzed.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Validation of the immuno-OCT endoscopy system based on:<br /><br>o Fluorescence molecular endoscopy;<br /><br>o Ex vivo fluorescence imaging;<br /><br>o Ex vivo immuno-OCT imaging;<br /><br>o Immunohistochemistry.</p><br>