Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

NCT02743975 | Terminated Phase 1 DMC

• 1 other identifier: NL50488.042.15
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Pancreatic Cancer; Pancreatic Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events

  Up to 4 weeks after tracer injection

Study Arms (1)

Treatment group

EXPERIMENTAL

Bevacizumab-800CW

Drug: Bevacizumab-800CW

Interventions

Bevacizumab-800CW DRUG

dose finding: 4.5mg; 10mg; 25mg; 50mg

Also known as: Bevacizumab-IRDye800CW

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Leiden University Medical Center: collaborator

Study Sites (3)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Leiden University Medical Center

Leiden, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Gooitzen van Dam, MD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Model Details: phase I/II safety and dose-finding study

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 19, 2016
• Study Start: December 1, 2016
• Primary Completion: February 26, 2018
• Study Completion: May 1, 2018
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

NL (3)