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

Phase 2
18 Years
Open (Enrolling)
Pancreatic Adenocarcinoma

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Trial Information

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

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

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.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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)

Outcome Time Frame:

90 days

Safety Issue:


Principal Investigator

Claudio Bassi, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


Italy: Ethics Committee

Study ID:




Start Date:

May 2011

Completion Date:

May 2012

Related Keywords:

  • Pancreatic Adenocarcinoma
  • locoregional cancer therapy
  • pancreatic cancer
  • unresectable pancreatic cancer
  • pancreatic adenocarcinoma
  • locally advanced, unresectable pancreatic cancer
  • pancreatic cancer tumor ablation
  • NanoKnife tumor ablation for pancreatic cancer
  • NanoKnife LEDC system tumor ablation
  • Non thermal ablation
  • Irreversible electroporation for pancreatic cancer treatment
  • IRE for unresectable pancreatic cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms