Back to resultsIrreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms (IRE)
Primary Purpose
Renal Pelvic and Ureteral Neoplasms
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rreversible electroporation (IRE)
NanoKnife
Sponsored by
About this trial
This is an interventional treatment trial for Renal Pelvic and Ureteral Neoplasms focused on measuring irreversible electroporation, Unresectable Renal Pelvic and Ureteral Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Renal Pelvic and Ureteral Neoplasms diagnosed by positive biopsy or non-invasive criteria,
- Not suitable for surgical resection,
- Eastern Cooperative Oncology Group (ECOG) score of 0-1,
- A prothrombin time ratio > 50%,
- Platelet count > 80x10^9/L,
- Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
- Able to comprehend and willing to sign the written informed consent form (ICF),
- Have a life expectancy of at least 3 months.
Exclusion Criteria:
- Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
- Any active implanted device (eg Pacemaker),
- Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
- Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
- Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Sites / Locations
- Biological treatment center in Fuda cancer hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
IRE Group
Control
Arm Description
irreversible electroporation for Unresectable Renal Pelvic and Ureteral Neoplasms
The patients without treatment
Outcomes
Primary Outcome Measures
Number of participants with Adverse events
Secondary Outcome Measures
Percentage of lesions that show no sign of recurrence 12 months after IRE
Voltage (A minimum and maximum range of voltage for safe and effective IRE)
A minimum and maximum range of voltage for safe and effective IRE will be
Progress free disease (PFS)
Overall survival (OS)
Patients will be followed for 36 months after IRE for OS analyzed.
Full Information
NCT ID
NCT02430779
First Posted
April 26, 2015
Last Updated
September 1, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
1. Study Identification
Unique Protocol Identification Number
NCT02430779
Brief Title
Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms
Acronym
IRE
Official Title
Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms: Phase I and Phase II Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fuda Cancer Hospital, Guangzhou
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (IRE) for unresectable Renal Pelvic and Ureteral Neoplasms.
Detailed Description
By enrolling patients with unresectable Renal Pelvic and Ureteral Neoplasms adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous IRE for unresectable Renal Pelvic and Ureteral Neoplasms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Pelvic and Ureteral Neoplasms
Keywords
irreversible electroporation, Unresectable Renal Pelvic and Ureteral Neoplasms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IRE Group
Arm Type
Experimental
Arm Description
irreversible electroporation for Unresectable Renal Pelvic and Ureteral Neoplasms
Arm Title
Control
Arm Type
No Intervention
Arm Description
The patients without treatment
Intervention Type
Procedure
Intervention Name(s)
rreversible electroporation (IRE)
Other Intervention Name(s)
NanoKnife
Intervention Description
Irreversible Electroportion For Unresectable Renal Pelvic and Ureteral Neoplasms guide with ultrasound or/and CT.
Intervention Type
Device
Intervention Name(s)
NanoKnife
Primary Outcome Measure Information:
Title
Number of participants with Adverse events
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Percentage of lesions that show no sign of recurrence 12 months after IRE
Time Frame
12 months
Title
Voltage (A minimum and maximum range of voltage for safe and effective IRE)
Description
A minimum and maximum range of voltage for safe and effective IRE will be
Time Frame
3 months
Title
Progress free disease (PFS)
Time Frame
12 months
Title
Overall survival (OS)
Description
Patients will be followed for 36 months after IRE for OS analyzed.
Time Frame
36 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Renal Pelvic and Ureteral Neoplasms diagnosed by positive biopsy or non-invasive criteria,
Not suitable for surgical resection,
Eastern Cooperative Oncology Group (ECOG) score of 0-1,
A prothrombin time ratio > 50%,
Platelet count > 80x10^9/L,
Ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post NanoKnife procedure,
Able to comprehend and willing to sign the written informed consent form (ICF),
Have a life expectancy of at least 3 months.
Exclusion Criteria:
Cardiac insufficiency, ongoing coronary artery disease or arrhythmia,
Any active implanted device (eg Pacemaker),
Women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception,
Have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the NanoKnife™ LEDC System,
Are in the opinion of the Investigator unable to comply with the visit schedule and protocol evaluations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lizhi Niu, PhD
Organizational Affiliation
Fuda Cancer Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Biological treatment center in Fuda cancer hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Irreversible Electroporation(IRE) For Unresectable Renal Pelvic and Ureteral Neoplasms
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