Optical Imaging for lymph node metastatic guidance in minimally Invasive esophagectomy
Recruiting
- Conditions
- Esophageal cancer
- Registration Number
- NL-OMON25371
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
·Patients scheduled for minimally invasive esophagectomy
·Suspected lymph node metastases based on EUS, PET or CT
·WHO performance score 0-2
·Aged 18 years or older
·Providing informed consent
Exclusion Criteria
·Known pregnancy or breastfeeding
·Known allergic reaction to Bevacizumab or other monoclonal antibody therapies
·Other invasive malignancy
·Inadequately controlled hypertension
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ·Intra-operative accumulation of Bevacizumab-800CW in VEGF-A overexpressing tissue as detected with intraoperative fluorescence imaging
- Secondary Outcome Measures
Name Time Method ·Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious and adverse reactions (SUSARs).<br>·Fluorescence signal in malignant and non-malignant tissue: signal-to-background ratio and tumor-to-normal ratio as measured by ex-vivo fluorescence measurements <br>·Correlation between localization of the fluorescently-labeled antibody and expression of the biomarker in tumor and healthy tissue.<br>·The effect of neoadjuvant chemoradiotherapy (nCRT) on the fluorescence signal; difference in results between patients treated with nCRT or without nCRT<br>·The optimal dose for further research, defined as the lowest dose at which a fluorescent signal is still detectable in vivo. <br><br>