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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Angiodynamics, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.
ClinicalTrials.gov Identifier:
NCT01369420
First received: June 7, 2011
Last updated: March 13, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Pancreatic Adenocarcinoma
Device: NanoKnife Low Energy Direct Current (LEDC) System Ablation
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Angiodynamics, Inc.:

Primary Outcome Measures:
  • Safety [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    • 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)


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]

    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


Estimated Enrollment: 10
Study Start Date: May 2011
Estimated Study Completion Date: May 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: NanoKnife Low Energy Direct Current (LEDC) System Ablation
    90 pulses of 70 microseconds each in duration will be administered per electrode pair.
    Other Names:
    • ◦ Low Energy Direct Current (LEDC) System
    • ◦ HVP01 Electroporation System
    • ◦ NanoKnife LEDC System
    • ◦ NanoKnife IRE System
    • ◦ Non-Thermal Irreversible Eletroporation (NTIRE) System
    • ◦ Angiodynamics IRE System
    • ◦ Non-Thermal Ablation
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01369420

Locations
Italy
Policlinico "G.B. Rossi", University of Verona, Department of Surgery
Verona, Italy, 37134
Sponsors and Collaborators
Angiodynamics, Inc.
Investigators
Principal Investigator: Claudio Bassi, M.D. Policlinico "G.B. Rossi", University of Verona, Department of Surgery
  More Information

Publications:

Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT01369420     History of Changes
Other Study ID Numbers: ONC-208
Study First Received: June 7, 2011
Last Updated: March 13, 2012
Health Authority: Italy: Ethics Committee
Italy: Ministry of Health

Keywords provided by Angiodynamics, Inc.:
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

Additional relevant MeSH terms:
Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014