Clinical trial NCT01369420: NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer
Official title: A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Keywords: 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
Lead sponsor: Angiodynamics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Safety
timeFrame: 90 days
Secondary outcomes:
measure: Efficacy
timeFrame: 90 days
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Policlinico "G.B. Rossi", University of Verona, Department of Surgery
Study officials:
affiliation: Policlinico "G.B. Rossi", University of Verona, Department of Surgery
name: Claudio Bassi, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varshney S, Sewkani A, Sharma S, Kapoor S, Naik S, Sharma A, Patel K. Radiofrequency ablation of unresectable pancreatic carcinoma: feasibility, efficacy and safety. JOP. 2006 Jan 11;7(1):74-8.
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