Irreversible Electroporation(IRE) For Unresectable Renal Tumors

Overview

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.

Full Title of Study: “Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: January 1, 2020

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 .

Interventions

  • Procedure: irreversible electroporation
    • Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors

Arms, Groups and Cohorts

  • Experimental: Group A
    • irreversible electroporation with voltage in level A for renal tumors
  • Experimental: Group B
    • irreversible electroporation with voltage in level B for renal tumors
  • Experimental: Group C
    • irreversible electroporation with voltage in level C for renal tumors

Clinical Trial Outcome Measures

Primary Measures

  • adverse effects
    • Time Frame: 1 month
    • adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
  • Quality of Life (QoL)
    • Time Frame: 2 months
    • Quality of Life assessed as WHOQOL-BREF.
  • procedural compliance
    • Time Frame: 3 months
    • compliance will be analyzed by 3 months of follow-up post procedure.

Secondary Measures

  • Recurrence rate
    • Time Frame: 12 months
    • 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)
    • Time Frame: 3 months
    • A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fuda Cancer Hospital, Guangzhou
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Lizhi Niu, PHD, Study Chair, Fuda Cancer Hospital
  • Overall Contact(s)
    • Lizhi Niu, PHD, m18922261535@163.com

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