Barrett's Esophagus
Conditions
Interventions
Patients will be topically (spray) administrerd with the tracer
Bevacizumab-IRDye800CW, ICG or Cetuximab-IRDye800CW, on the mucosa of the
esophagus. ICG could be intraveniously adminstered in a low
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Suspicion or diagnosed LGD, HGD or superficial EAC and planned diagnostic and/or therapeutic - endoscopy. - Age: 18 years or older. - Written informed consent.
Exclusion criteria
Exclusion criteria: - Patients younger than 18 years old - Submucosal and invasive EAC; EAC with TNM-classification other than T1. - Radiation therapy for esophageal cancer - Immunoglobulin allergy - Chemotherapy, immunotherapy or surgery 28 days before administration of the tracer - Prior Bevacizumab or Cetuximab treatment - Patients using anti-epileptic drugs (only exclusion criterium for the ICG subgroup). - Non-adjustable hypertension - Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. - Pregnancy or breast feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Macroscopic fluorescent signal levels and tracer distribution observed by flexible fluorescence molecular endoscopy. - Macroscopic quantification of the fluorescent signal observed by means of the MDSFR/SFF spectroscopy probe. - Microscopic distribution and (semi-quantitative) fluorescent signal intensity of bevacizumab-IRDye800CW in the EMR specimen and biopsies correlated to VEGF distribution and level of expression. - Ex-vivo we will perform binding experiments with tracers against GREM1, -SULF1 and -PRKCi on the fresh EMR and surgical EC specimen if available and compare them against the in-vivo WLE/NIR-FME findings. We will analyze the sensitivity and specificity of the novel markers alone or in combination. The targeting moieties will be coupled with different fluorophores allowing for multi-parametric analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| - The correlation between fluorescence intensity and the grade of VEGF expression on immunohistochemistry, in (pre)malignant lesions of the esophagus. - Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARs). - Investigate the binding specificity of Bevacizumab-800CW by comparing the fluorescent intensity results with the results with ICG and Cetuximab-800CW | — |
Countries
Netherlands
Outcome results
None listed