Esophageal cancer
Conditions
Interventions
Targeted fluorescence imaging
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Inclusion criteria
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
Exclusion criteria: · Known pregnancy or breastfeeding · Known allergic reaction to Bevacizumab or other monoclonal antibody therapies · Other invasive malignancy · Inadequately controlled hypertension
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ·Intra-operative accumulation of Bevacizumab-800CW in VEGF-A overexpressing tissue as detected with intraoperative fluorescence imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| · Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious and adverse reactions (SUSARs). · Fluorescence signal in malignant and non-malignant tissue: signal-to-background ratio and tumor-to-normal ratio as measured by ex-vivo fluorescence measurements · Correlation between localization of the fluorescently-labeled antibody and expression of the biomarker in tumor and healthy tissue. · The effect of neoadjuvant chemoradiotherapy (nCRT) on the fluorescence signal; difference in results between patients treated with nCRT or without nCRT · The optimal dose for further research, defined as the lowest dose at which a fluorescent signal is still detectable in vivo. | — |
Contacts
Public ContactDidi de Gouw
Radboudumc
Outcome results
None listed