Near-infrared Image Guided Surgery in Pancreatic Adenocarcinoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Pancreatic Cancer Pancreatic Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

phase I/II safety and dose-finding study

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Treatment group

Bevacizumab-800CW

Group Type EXPERIMENTAL

Bevacizumab-800CW

Intervention Type DRUG

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

Interventions

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Bevacizumab-800CW

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

Intervention Type DRUG

Other Intervention Names

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Bevacizumab-IRDye800CW

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No