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

Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01369420
• Other study ID #: ONC-208
• Status: Completed
• Phase: Phase 2
• First received: June 7, 2011
• Last updated: November 7, 2016
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: November 2016
• Source: Angiodynamics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics CommitteeItaly: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Device:
• NanoKnife Low Energy Direct Current (LEDC) System Ablation
90 pulses of 70 microseconds each in duration will be administered per electrode pair.

Locations

Country	Name	City	State
Italy	Policlinico "G.B. Rossi", University of Verona, Department of Surgery	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Angiodynamics, Inc.

Country where clinical trial is conducted

Italy, 

References & Publications (10)

Chan YC, Leung PS. Acute pancreatitis: animal models and recent advances in basic research. Pancreas. 2007 Jan;34(1):1-14. Review. — View Citation

Connor S, Raraty MG, Neoptolemos JP, Layer P, Rünzi M, Steinberg WM, Barkin JS, Bradley EL 3rd, Dimagno E. Does infected pancreatic necrosis require immediate or emergency debridement? Pancreas. 2006 Aug;33(2):128-34. — View Citation

Elias D, Baton O, Sideris L, Lasser P, Pocard M. Necrotizing pancreatitis after radiofrequency destruction of pancreatic tumours. Eur J Surg Oncol. 2004 Feb;30(1):85-7. — View Citation

Freitag M, Standl TG, Kleinhans H, Gottschalk A, Mann O, Rempf C, Bachmann K, Gocht A, Petri S, Izbicki JR, Strate T. Improvement of impaired microcirculation and tissue oxygenation by hemodilution with hydroxyethyl starch plus cell-free hemoglobin in acute porcine pancreatitis. Pancreatology. 2006;6(3):232-9. — View Citation

Hadjicostas P, Malakounides N, Varianos C, Kitiris E, Lerni F, Symeonides P. Radiofrequency ablation in pancreatic cancer. HPB (Oxford). 2006;8(1):61-4. doi: 10.1080/13651820500466673. — View Citation

Matsui Y, Nakagawa A, Kamiyama Y, Yamamoto K, Kubo N, Nakase Y. Selective thermocoagulation of unresectable pancreatic cancers by using radiofrequency capacitive heating. Pancreas. 2000 Jan;20(1):14-20. — View Citation

Raraty MG, Connor S, Criddle DN, Sutton R, Neoptolemos JP. Acute pancreatitis and organ failure: pathophysiology, natural history, and management strategies. Curr Gastroenterol Rep. 2004 Apr;6(2):99-103. Review. — View Citation

Spiliotis JD, Datsis AC, Michalopoulos NV, Kekelos SP, Vaxevanidou A, Rogdakis AG, Christopoulou AN. Radiofrequency ablation combined with palliative surgery may prolong survival of patients with advanced cancer of the pancreas. Langenbecks Arch Surg. 2007 Jan;392(1):55-60. — View 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. — View Citation

Wu Y, Tang Z, Fang H, Gao S, Chen J, Wang Y, Yan H. High operative risk of cool-tip radiofrequency ablation for unresectable pancreatic head cancer. J Surg Oncol. 2006 Oct 1;94(5):392-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	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	Yes
Secondary	Efficacy	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	No