Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer (NPEF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier:
NCT01463709
First received: October 26, 2011
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)


Condition Intervention Phase
Basal Cell Carcinomas
Device: PulseCure pulse generator and Derm-pulse electrode
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer

Resource links provided by NLM:


Further study details as provided by Children's Hospital & Research Center Oakland:

Primary Outcome Measures:
  • Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas. [ Time Frame: One year ] [ Designated as safety issue: Yes ]
    1. Conduct a non-significant risk feasibility clinical trial treating BCCs on the trunk of up to 9 Basal Cell Nevus Syndrome patients with BioElectroMed's PulseCure pulse generator and Derm-Pulse electrode to both demonstrate the safety of nsPEF therapy and identify the optimal pulse number for ablating BCCs.


Secondary Outcome Measures:
  • Determine the efficacy of the PulseCure pulse generator using the optimal pulse number. [ Time Frame: one year ] [ Designated as safety issue: No ]
    2. Conduct a non-significant risk Pilot Clinical Trial treating BCCs on the trunk of 20 patients with sporadic BCCs using the optimal pulse number determined from the feasibility trial to assess the efficacy of this technique.


Enrollment: 4
Study Start Date: October 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nanopulse
Administer nano pulse to lesion for varying time intervals.
Device: PulseCure pulse generator and Derm-pulse electrode

PulseCure 100 ns pulse generator: generates 30 kV/cm electric pulses 100 ns long to trigger apoptosis in cells between the electrodes.

NanoBlate: Delivery device to treat 5 mm wide skin lesions with 100 ns pulses from PulseCure

Other Name: BioElectroMed

Detailed Description:

The purpose of this study is to determine if low energy, non-thermal, 100 ns pulses can ablate BCCs. The investigators consider this a non-significant risk study because our PulseCure system only applies 0.4 watts to the skin compared to the 40 watts applied by the currently used electrosurgical unit to remove skin lesions, the Hyfrecator. Since the PulseCure applies 1/100 of the energy and does not even heat the skin significantly, it represents a non-significant risk to the patient. Our study will provide the first data on the response of BCCs to these 100 ns pulses. The investigators will first treat three BCCs on BCNS patients with different pulse numbers to determine the pulse number needed to ablate. Once the investigators have the optimal pulse number, the investigators will use it to treat 20 normal patients with sporadic BCCs on their trunks. This should provide sufficient data to conclude whether or not nsPEF can ablate BCCs on normal individuals.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Study subjects must have had diagnosed at least one BCCon their trunk
  2. The subject is from 18-75 years of age, inclusive.
  3. The subject must sign and date all informed consent statements.

Exclusion Criteria:

  1. The subject is exhibiting signs of a bacterial or viral infection, including fever.
  2. The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
  3. The subject has a pace maker or other electronic device implanted
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01463709

Locations
United States, California
Children's Hospital Research Center Oakland
Oakland, California, United States, 94609
Sponsors and Collaborators
Children's Hospital & Research Center Oakland
Investigators
Principal Investigator: Ervin E Epstein, MD Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Children's Hospital & Research Center Oakland
ClinicalTrials.gov Identifier: NCT01463709     History of Changes
Other Study ID Numbers: 2011-049
Study First Received: October 26, 2011
Last Updated: February 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital & Research Center Oakland:
basal cell carcinoma
Basal Cell Nevus Syndrome
Electric Field
Nanosecond pulse

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Basal Cell
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Basal Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 20, 2014