NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer

November 7, 2016 updated by: Angiodynamics, Inc.

A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study

The purpose of this study is to evaluate the safety and feasibility of the NanoKnife Low Energy Direct Current (LEDC) System when used to treat unresectable pancreatic adenocarcinoma. Safety will be reviewed by means of analysis of adverse events, including serious adverse events, laboratory data, physician exam findings, and vital signs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Verona, Italy, 37134
        • Policlinico "G.B. Rossi", University of Verona, Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. male or female
  2. >/= 18 years of age
  3. meets criteria for locally advanced unresectable pancreatic adenocarcinoma, as radiographically proven pancreatic cancer as determined by a surgical oncologist via pancreatic CT or who were initially thought to be resectable; however at the time of surgery were upstaged to unresectability, via direct visualization
  4. tumor size must be < 4 cm and must be measurable
  5. must have an INR <1.5
  6. must be unresponsive to chemotherapy as demonstrated with either CT or MR imaging and not have taken any chemotherapy agents within 14 days of treatment with the NanoKnife LEDC System
  7. are willing and able to comply with the protocol requirements
  8. are able to comprehend and willing to sign an Informed Consent Form (ICF)

Exclusion Criteria:

  1. a baseline creatinine reported as > 2.0 mg/dL
  2. have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0
  3. inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
  4. known history of contrast allergy that cannot be medically managed
  5. known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
  6. unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc)
  7. women who are pregnant or currently breast feeding
  8. women of childbearing potential who are not utilizing an acceptable method of contraception
  9. have taken an investigational agent within 30 days of visit 1
  10. have implanted cardiac pacemakers or defibrillators
  11. have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
  12. have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
  13. have a recent history of myocardial infarction (within the past 2 months)
  14. have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 90 days
  • reported adverse events and adverse effects/events (serious and non serious),
  • unanticipated adverse events and device complaints,
  • safety laboratory tests (hematology, chemistry, amylase, lipase),
  • vital signs,
  • physical findings (including symptoms, vital signs and weight changes)
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 90 days

Evaluation of short term efficacy based upon tumor evaluation and symptomatic response as defined by:

  • imaging will be used to evaluate changes in tumor size in addition to evaluating the completeness of ablation,
  • tumor evaluation by evaluating changes in CA-19-9 marker,
  • symptomatic changes of quality of life questionnaires,
  • physician assessment of the performance status of the subject,
  • pain assessment and subject analgesic consumption,
  • assessment of tumor for downstaging to resectability at the time of imaging
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiodynamics, Inc.

Investigators

  • Principal Investigator: Claudio Bassi, M.D., Policlinico "G.B. Rossi", University of Verona, Department of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 7, 2011

First Submitted That Met QC Criteria

June 8, 2011

First Posted (Estimate)

June 9, 2011

Study Record Updates

Last Update Posted (Estimate)

November 8, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONC-208

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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