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

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ClinicalTrials.gov Identifier: NCT02335827
Recruitment Status : Recruiting
First Posted : January 12, 2015
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Fuda Cancer Hospital, Guangzhou

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

Condition or disease Intervention/treatment Phase
Renal Tumor Procedure: irreversible electroporation Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial
Actual Study Start Date : January 1, 2015
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Cancer

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




Primary Outcome Measures :
  1. adverse effects [ Time Frame: 1 month ]
    adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.

  2. Quality of Life (QoL) [ Time Frame: 2 months ]
    Quality of Life assessed as WHOQOL-BREF.

  3. procedural compliance [ Time Frame: 3 months ]
    compliance will be analyzed by 3 months of follow-up post procedure.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Other Outcome Measures:
  1. Progress free disease (PFS) [ Time Frame: 12 months ]
    Patients will be followed for 12 months after IRE for PFS assessing.

  2. Overall survival (OS) [ Time Frame: 36 months ]
    Patients will be followed for 36 months after IRE for OS analyzed.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02335827


Contacts
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Contact: Lizhi Niu, PHD m18922261535@163.com

Locations
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China, Guangdong
Fuda Cancer Hospital Recruiting
Guangzhou, Guangdong, China, 510665
Contact: Quincy LH He, Dr.       m18922261535@163.com   
Sponsors and Collaborators
Fuda Cancer Hospital, Guangzhou
Investigators
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Study Chair: Lizhi Niu, PHD Fuda Cancer Hospital

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Responsible Party: Fuda Cancer Hospital, Guangzhou
ClinicalTrials.gov Identifier: NCT02335827     History of Changes
Other Study ID Numbers: IRE-001
First Posted: January 12, 2015    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: March 2019
Keywords provided by Fuda Cancer Hospital, Guangzhou:
irreversible electroporation
renal tumor
Additional relevant MeSH terms:
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Kidney Neoplasms
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases