Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

Pancreatic Cancer Clinical Trial

— PENGUIN  

Official title:

Intraoperative Detection of Cancer Tissue in Pancreatic Adenocarcinoma Using a VEGF-targeted Optical Fluorescent Imaging Tracer, A Multicentre Feasibility Dose Escalation Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02743975
• Other study ID #: NL50488.042.15
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: December 1, 2016
• Est. completion date: May 1, 2018

Study information

• Verified date: January 2020
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There is a need for better visualization of resection margins and detection of small tumor deposits during surgery for pancreatic cancer. Optical molecular imaging of pancreatic ductal adenocarcinoma associated biomarkers is a promising technique to accommodate this need. The biomarker Vascular Endothelial Growth Factor (VEGF-A) is overexpressed in pancreatic cancer tissue versus normal tissue and has proven to be a valid target for molecular imaging. VEGF-A can be targeted by the monoclonal antibody bevacizumab. Monoclonal antibodies can be labeled by the near-infrared (NIR) fluorescent dye IRDye800CW (800CW). The investigators hypothesize that bevacizumab-800CW accumulates in VEGF expressing cancer, enabling pancreatic cancer visualization using a NIR intraoperative camera system. In this pilot intervention study the investigators will determine the optimal dosage of bevacizumab-800CW (4,5 10, 25 or 50mg) to detect pancreatic cancer tissue intraoperatively.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 1, 2018
• Est. primary completion date: February 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Patients with clinical suspicion of pancreatic head cancer who are scheduled to undergo surgical intervention with curative intent

• World Health Organization (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 or other monoclonal antibody therapies.

• Inadequately controlled hypertension with or without current antihypertensive medications

• Within 6 months prior to inclusion: myocardial infarction, Transient Ischemic Attack, Cerebral Vascular Accident, pulmonary embolism, uncontrolled chronic hepatic failure, unstable angina pectoris.

• Anticoagulant therapy with vitamine K antagonists

• Patients receiving Class 1A (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents

• Evidence of QTc (corrected QT interval) prolongation on pretreatment ECG (greater than 44ms in males of greater than 450ms in females)

• Magnesium, potassium and calcium below the lower limit of normal range.

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Cancer

Intervention

Drug:
• Bevacizumab-800CW
dose finding: 4.5mg; 10mg; 25mg; 50mg

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Radboud University Medical Center	Nijmegen

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Center Groningen	Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tracer accumulation in tumor tissue vs normal pancreatic tissue assessed by intraoperatively and ex vivo measuring of the mean fluorescent intensity	Mean Fluorescent Intensity (MFI) measured in tumor tissue compared to normal pancreatic tissue at macroscopic and microscopic level	up to 6 months
Primary	Finding optimal dose of Bevacizumab-800CW for intraoperative imaging of pancreatic cancer measured by calculating Target to Background ratios (TBR)	TBR of each dose group assessed by intraoperative imaging as well as ex vivo imaging	3 days after tracer injection
Secondary	Number of participants with treatment-related adverse events		Up to 4 weeks after tracer injection