No registrations found.
ID
Source
Brief title
Health condition
Esophageal cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
·Intra-operative accumulation of Bevacizumab-800CW in VEGF-A overexpressing tissue as detected with intraoperative fluorescence imaging
Secondary outcome
· 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.
Background summary
There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for esophageal cancer. Optical molecular imaging of esophageal adenocarcinoma (EAC) associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in esophageal adenocarcinoma and its lymph node metastases and has proven to be a suitable target for molecular imaging
Study objective
We hypothesize that the VEGF-targeting antibody Bevacizumab labeled with the fluorophore IRDye800CW (Bevacizumab-800CW) accumulates in VEGF-A expressing cancer, enabling esophageal cancer visualization using a NIR minimally invasive intra-operative camera system. In this pilot intervention study we will determine the optimal dosage of Bevacizumab-800CW (4.5, 10 or 25 mg) to detect esophageal cancer tissue intra-operatively.
Study design
-
Intervention
Targeted fluorescence imaging
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5969 |
| NTR-old | NTR6343 |
| CCMO | NL61189.042.18 |
| OMON | NL-OMON50437 |