BEVACIZUMAB for Barrett's esophagus|Colon carcinoma|Gastrointestinal dysplasia

Inclusion criteria

• {"criterion_text":"- Indication for a therapeutic endoscopy procedure (EMR or ESD)"}
• {"criterion_text":"- Age ≥ 18"}
• {"criterion_text":"- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Radiation therapy for esophageal or colorectal cancer"}
• {"criterion_text":"- History of infusion reactions to Bevacizumab or other monoclonal antibodies"}
• {"criterion_text":"- Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer"}
• {"criterion_text":"- Non-adjustable hypertension"}
• {"criterion_text":"- Medical or psychiatric conditions that compromise the patient’s ability to give informed consent"}
• {"criterion_text":"- Pregnancy or breast feeding; a negative pregnancy test must be available for women of childbearing potential"}
• {"criterion_text":"- Pacemaker"}

Primary endpoints

• {"endpoint_text":"- Safety evaluation of immuno-OCT imaging: Number of adverse device-related events (ADE’s) and serious adverse device-related events (SADE’s).","definition_or_measurement_approach":"Count of adverse device-related events (ADEs) and serious adverse device-related events (SADEs) reported during the study."}
• {"endpoint_text":"- Feasibility of in vivo immuno-OCT imaging and interpretation of the in vivo immuno-OCT results","definition_or_measurement_approach":"Assessment of ability to obtain in vivo immuno-OCT images and interpret the resulting images/results (stated: \"This will not be statistically analysed.\")."}

Secondary endpoints

• {"endpoint_text":"- 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;","definition_or_measurement_approach":"Validation/comparison of immuno-OCT results against fluorescence molecular endoscopy (FME) imaging, ex vivo fluorescence signals correlated with histopathology, and correlation of in vivo and ex vivo immuno-OCT imaging to histopathological analysis."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-01-2024

Latest Decision Or Authorization Date

22-01-2024

Processing Time Days

12

Number Of Sites

1

Number Of Participants

15

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands