Intraoperative detection of tumor tissue in pancreatic cancer using a VEGF-targeted optical fluorescent imaging tracer

Completed

Conditions: cancer of the pancreas
pancreatic cancer
10017990
10017991

Registration Number: NL-OMON44846

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 26

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

* 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>ntraoperative assessment of positive margins as well as positive lymphnodes and<br /><br>metastases based on fluorescent images. <br /><br> Off table imaging of surgical specimen directly after excision to identify<br /><br>positive margins, lymphnodes and metastases based on ex vivo fluorescent images.<br /><br>* Standard histopathological examination to compare the fluorescent signals<br /><br>with the presence of malignancy as well as to compare non-fluorescence lesions<br /><br>with the absence of malignancy.<br /><br>* Calculating target to background ratios in fluorescence images obtained<br /><br>during and directly after the surgical procedure and fluorescence images<br /><br>obtained during ex vivo analyses in bread loaf slices and in histological<br /><br>slices (odyssey scanner, fluorescence microscopy.)<br /><br>* Adverse events (AE), serious adverse events (SAE), and suspected unexpected<br /><br>serious adverse reactions (SUSARs). </p><br>

Secondary Outcome Measures