Clinical trial · Interventional
NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer
A Safety Evaluation of the NanoKnife Low Energy Direct Current (LEDC) System in Subjects With Locally Advanced Unresectable Pancreatic Cancer - A Pilot Study
NCT01369420CI-TRIAL-00024745completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NanoKnife Low Energy Direct Current (LEDC) System Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety
- timeFrame
- 90 days
- 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)
Secondary outcomes (1)
- measure
- Efficacy
- timeFrame
- 90 days
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (10)
- BACKGROUNDVarshney 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. PMID 16407624
- BACKGROUNDSpiliotis 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. doi: 10.1007/s00423-006-0098-5. Epub 2006 Nov 7. PMID 17089173
- BACKGROUNDHadjicostas 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. PMID 18333241
- BACKGROUNDWu 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. doi: 10.1002/jso.20580. PMID 16967436
- BACKGROUNDMatsui 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. doi: 10.1097/00006676-200001000-00002. PMID 10630378
- BACKGROUNDElias 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. doi: 10.1016/j.ejso.2003.10.013. PMID 14736529
- BACKGROUNDConnor S, Raraty MG, Neoptolemos JP, Layer P, Runzi 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. doi: 10.1097/01.mpa.0000234074.76501.a6. No abstract available.