A pilot intervention study for the use of VEGF-targeted Fluorescence Near-Infrared (NIR) Endoscopy in (pre)malignant Esophageal Lesions
Completed
- Conditions
- Esophageal adenocarcinomaesophageal cancer1001799010017991
- Registration Number
- NL-OMON41226
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
- Identified high grade dysplasia (HGD) or intramucosal adenocarcinoma (EAC; T1) and therefore candidate for endoscopic therapy using EMR.
- Mentally competent person, age 18 years or older
- Written informed consent.
- Adequate potential for follow-up.
Exclusion Criteria
- Medical or psychiatric conditions that compromise the patient*s ability to give informed consent.
- Submucosal and invasive EAC ; EAC with TNM-classification other than T1
- Concurrent uncontrolled medical conditions or medical conditions which disqualify for an EMR procedure.
- Previously preformed therapeutic endoscopic procedures.
- Pregnancy or breast feeding.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Macroscopic fluorescent signal levels and tracer distribution observed by<br /><br>flexible NIR fluorescence imaging; (semi)quantitative.<br /><br>- Microscopic distribution and objecifying of the fluorescent signal intensity<br /><br>of bevacizumab-IRDye800CW in vivo using the CLE cellvizio probe-based imaging<br /><br>system.<br /><br>- Microscopic distribution and (semi)quantitative fluorescent signal intensity<br /><br>of bevacizumab-IRDye800CW in the EMR specimen and biopsies correlated to VEGF<br /><br>distribution and level of expression</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Distinguish and objectify in vivo the NIR fluorescent signal of<br /><br>Bevacizumab-800CW by means of the CLE cellvizio probe-based imaging system.<br /><br>- The correlation between fluorescence intensity and the grade of VEGF<br /><br>expression on immunohistochemistry, in (pre)malignant lesions of the esophagus.<br /><br>- Adverse events (AE), serious adverse events (SAE), and suspected unexpected<br /><br>serious adverse reactions (SUSARs). </p><br>