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AzTrials

Pancreatic AdenocarcinomaPhase 2NCT01369420

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

A Phase 2 study testing NanoKnife Low Energy Direct Current (LEDC) System Ablation in people with Pancreatic Adenocarcinoma, run by Angiodynamics, Inc. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
NanoKnife Low Energy Direct Current (LEDC) System Ablation
Type of treatment
Medical device
How many people
10 participants
Where
1 siteItaly
Study dates
May 2011to Sep 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • male or female
  • >/= 18 years of age
  • 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
  • tumor size must be < 4 cm and must be measurable
  • must have an INR <1.5
  • 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
  • are willing and able to comply with the protocol requirements
  • are able to comprehend and willing to sign an Informed Consent Form (ICF)

Who cannot join

  • a baseline creatinine reported as > 2.0 mg/dL
  • have any reported baseline lab values with a grade 3 or 4 toxicity as defined by the CTCAE Version 3.0
  • inability to stop antiplatelet and Coumadin therapy for 7 days prior to and 7 days post treatment with the NanoKnife System
  • known history of contrast allergy that cannot be medically managed
  • known hypersensitivity to the metal in the electrodes (stainless steel 304L) that cannot be medically managed
  • unable to be treated with a muscle blockade agent (e.g. pancuronium bromide, atracurium, cisatracurium, etc)
Show all 14Show fewer
  • women who are pregnant or currently breast feeding
  • women of childbearing potential who are not utilizing an acceptable method of contraception
  • have taken an investigational agent within 30 days of visit 1
  • have implanted cardiac pacemakers or defibrillators
  • have implanted electronic devices or implants with metal parts in the immediate vicinity of a lesion
  • have a history of epilepsy or cardiac arrhythmia (atrial or ventricular fibrillation)
  • have a recent history of myocardial infarction (within the past 2 months)
  • have Q-T intervals greater than 550 ms unless treated with an Accysync Model 72 synchronization system controlling the NanoKnife system's output pulses.

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Verona, Verona, 37134

Other trials in Italy

About this study

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

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.

Being tested
NanoKnife Low Energy Direct Current (LEDC) System Ablation
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
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NanoKnife Low Energy Direct Current (LEDC) System AblationDevice

    Also called ◦ Low Energy Direct Current (LEDC) System, ◦ HVP01 Electroporation System, ◦ NanoKnife LEDC System, ◦ NanoKnife IRE System

    90 pulses of 70 microseconds each in duration will be administered per electrode pair.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 90 days

Secondary outcomes (1)

  1. 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

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionDec 2011
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01369420
Sponsor's protocol ID
ONC-208
Status last verified
Nov 2016
First submitted
7 Jun 2011
Last updated
8 Nov 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 16407624

  • 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. doi: 10.1007/s00423-006-0098-5. Epub 2006 Nov 7.

    PubMed 17089173

  • 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.

    PubMed 18333241

  • 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. doi: 10.1002/jso.20580.

    PubMed 16967436

  • 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. doi: 10.1097/00006676-200001000-00002.

    PubMed 10630378

  • 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. doi: 10.1016/j.ejso.2003.10.013.

    PubMed 14736529

  • Connor 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.

    PubMed 16868477

  • 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. doi: 10.1007/s11894-004-0035-0.

    PubMed 15191686

  • Chan YC, Leung PS. Acute pancreatitis: animal models and recent advances in basic research. Pancreas. 2007 Jan;34(1):1-14. doi: 10.1097/01.mpa.0000246658.38375.04.

    PubMed 17198179

  • 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. doi: 10.1159/000091962. Epub 2006 Mar 9.

    PubMed 16534248

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NanoKnife Low Energy Direct Current (LEDC) System Ablation in people with Pancreatic Adenocarcinoma, run by Angiodynamics, Inc. at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01369420, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2016.

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