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

September 1, 2021 updated by: Fuda Cancer Hospital, Guangzhou

Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 .

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510665
        • Fuda Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
irreversible electroporation with voltage in level A for renal tumors
Procedure: irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Experimental: Group B
irreversible electroporation with voltage in level B for renal tumors
Procedure: irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
Experimental: Group C
irreversible electroporation with voltage in level C for renal tumors
Procedure: irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 36 months
Patients will be followed for 36 months after IRE for OS analyzed.
36 months
Progress free disease (PFS)
Time Frame: 12 months
Patients will be followed for 12 months after IRE for PFS assessing.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fuda Cancer Hospital, Guangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

May 20, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

January 2, 2015

First Submitted That Met QC Criteria

January 7, 2015

First Posted (Estimate)

January 12, 2015

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRE-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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