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Irreversible Electroporation(IRE) For Unresectable Renal Tumors (IRE)

Primary Purpose

Renal Tumor

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
irreversible electroporation
Sponsored by
Fuda Cancer Hospital, Guangzhou
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Tumor focused on measuring irreversible electroporation, renal tumor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unresectable kidney tumors
  • patients refused surgical therapy
  • Karnofsky-index >70%
  • Age ≥ 18 and ≤ 80 years
  • life expectancy ≥ 12 month
  • compliance of the patient taking part in a study
  • informed consent

Exclusion Criteria:

  • violation against one or more inclusion criteria
  • an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
  • QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
  • active infection or severe health interference, that make taking part in a study unfeasible
  • pregnancy, lactation period
  • general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
  • psychiatric disorders that make taking part in a study or giving informed consent unfeasible
  • haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
  • thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50
  • untreated urinary retention
  • severe hepatic dysfunction
  • any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
  • taking part in another clinical study for renal tumor.

Sites / Locations

  • Fuda Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

irreversible electroporation with voltage in level A for renal tumors

irreversible electroporation with voltage in level B for renal tumors

irreversible electroporation with voltage in level C for renal tumors

Outcomes

Primary Outcome Measures

adverse effects
adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
Quality of Life (QoL)
Quality of Life assessed as WHOQOL-BREF.
procedural compliance
compliance will be analyzed by 3 months of follow-up post procedure.

Secondary Outcome Measures

Recurrence rate
efficacy assessment by percentage of lesions that show no sign of recurrence 12 months after the initial IRE procedure) of IRE for renal tumor via cross-sectional imaging and pathological examination.
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 analyzed for optimal choice.

Full Information

First Posted
January 2, 2015
Last Updated
September 1, 2021
Sponsor
Fuda Cancer Hospital, Guangzhou
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1. Study Identification

Unique Protocol Identification Number
NCT02335827
Brief Title
Irreversible Electroporation(IRE) For Unresectable Renal Tumors
Acronym
IRE
Official Title
Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2015 (Actual)
Primary Completion Date
May 20, 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 investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.
Detailed Description
By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Tumor
Keywords
irreversible electroporation, renal tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
irreversible electroporation with voltage in level A for renal tumors
Arm Title
Group B
Arm Type
Experimental
Arm Description
irreversible electroporation with voltage in level B for renal tumors
Arm Title
Group C
Arm Type
Experimental
Arm Description
irreversible electroporation with voltage in level C for renal tumors
Intervention Type
Procedure
Intervention Name(s)
irreversible electroporation
Intervention Description
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Primary Outcome Measure Information:
Title
adverse effects
Description
adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
Time Frame
1 month
Title
Quality of Life (QoL)
Description
Quality of Life assessed as WHOQOL-BREF.
Time Frame
2 months
Title
procedural compliance
Description
compliance will be analyzed by 3 months of follow-up post procedure.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Recurrence rate
Description
efficacy assessment by percentage of lesions that show no sign of recurrence 12 months after the initial IRE procedure) of IRE for renal tumor via cross-sectional imaging and pathological examination.
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 analyzed for optimal choice.
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Progress free disease (PFS)
Description
Patients will be followed for 12 months after IRE for PFS assessing.
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
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unresectable kidney tumors patients refused surgical therapy Karnofsky-index >70% Age ≥ 18 and ≤ 80 years life expectancy ≥ 12 month compliance of the patient taking part in a study informed consent Exclusion Criteria: violation against one or more inclusion criteria an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2 QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible active infection or severe health interference, that make taking part in a study unfeasible pregnancy, lactation period general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation psychiatric disorders that make taking part in a study or giving informed consent unfeasible haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50 untreated urinary retention severe hepatic dysfunction any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment) taking part in another clinical study for renal tumor.
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
Fuda Cancer Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510665
Country
China

12. IPD Sharing Statement

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Irreversible Electroporation(IRE) For Unresectable Renal Tumors

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