cancer of the pancreas pancreatic cancer
Conditions
Interventions
In part one a maximum of 12 patients will receive a single bolus injection of
Bevacizumab-800CW three days before surgery. During surgery seven imaging
moments are defined in which the near infrared
fluorescence
pancreatic cancer
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Age * 18 years. * Patients with clinical suspicion of pancreatic cancer who are scheduled to undergo surgical intervention with curative intent * WHO performance score 0-2. * Signed written informed consent
Exclusion criteria
Exclusion criteria: * Medical or psychiatric conditions that compromise the patient*s ability to give informed consent. * Other invasive malignancy * Pregnant or lactating women. Documentation of a negative pregnancy test must be available for woman of childbearing potential. Woman of childbearing potential are pre- menopausal women with intact reproductive organs and women less than two years after menopause. * Prior neo-adjuvant chemo- of radiotherapy * History of infusion reactions to bevacizumab * Inadequately controlled hypertension with or without current antihypertensive medications * Within 6 months prior to inclusion: myocardial infarction, TIA, CVA pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ntraoperative assessment of positive margins as well as positive lymphnodes and metastases based on fluorescent images. * * Off table imaging of surgical specimen directly after excision to identify positive margins, lymphnodes and metastases based on ex vivo fluorescent images. * Standard histopathological examination to compare the fluorescent signals with the presence of malignancy as well as to compare non-fluorescence lesions with the absence of malignancy. * Calculating target to background ratios in fluorescence images obtained during and directly after the surgical procedure and fluorescence images obtained during ex vivo analyses in bread loaf slices and in histological slices (odyssey scanner, fluorescence microscopy.) * Adverse events (AE), serious adverse events (SAE), and suspected unexpected serious adverse reactions (SUSARs). | — |
Secondary
| Measure | Time frame |
|---|---|
| net | — |
Countries
The Netherlands
Outcome results
None listed