IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.
IRENE
Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).
5 other identifiers
interventional
20
1 country
4
Brief Summary
The aim of the study is the evaluation of the ablation efficiency of the percutaneous irreversible electroporation (IRE) as primary ablation therapy of locally confined renal cell carcinoma (≤4cm, see inclusion and exclusion criteria). The ablation success will be proofed by magnet resonance imaging (MRI) and histologically after partial kidney resection or nephrectomy 4 weeks after IRE. Hypotheses: Kidney tumors ≤4cm can be ablated completely by percutaneous IRE. Surrounded structures and renal tissue can be preserved.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2013
Typical duration for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 15, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedNovember 19, 2014
November 1, 2014
2.2 years
October 15, 2013
November 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
analysis of ablation effectiveness of non-metastatic renal tumors <4cm 28 days by after irreversible electroporation (NanoKnife, AngioDynamics Inc.) by histopathological examination of partial kidney resection specimens
onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis
28 days
Secondary Outcomes (1)
safety
4 month
Study Arms (1)
renal tumor <4cm, suspected RCC
EXPERIMENTALIntervention/ Time point: Irreversible Electroporation at day 0 of each patient.
Interventions
Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.
Eligibility Criteria
You may qualify if:
- one or more localized, resectable kidney tumors (≤4 cm) suspicious of malignancy or histology -proven renal cell cancer (RCC)
- patients desire for therapy and surgical therapy
- Karnofsky-index \>70%
- Age ≥ 18 years
- life expectancy ≥ 12 month
- compliance of the patient taking part in a study
- informed consent
You may not qualify if:
- cardial pacemaker or other electrical implants
- QT-interval \>550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
- known cardial ejection fraction \< 30% or NYHA III or III-IV
- known epilepsy
- second malignancy (except basal-cell carcinoma and cervical carcinoma in situ)
- immunosuppression or HIV-positive patients
- active infection or severe health interference, that make taking part in a study unfeasible
- pregnancy, lactation period, no contraception
- metastatic disease
- palliative status
- running or executed RCC therapy
- taking part in another clinical study for RCC
- inoperable
- rejection of interventional or surgical therapy by the patient
- circulatory instability
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Department of Pathology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
Department of Radiology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120, Germany
MVZ Hanse Histologikum GmbH Hamburg
Hamburg, 22547, Germany
Related Publications (3)
Liehr UB, Wendler JJ, Blaschke S, Porsch M, Janitzky A, Baumunk D, Pech M, Fischbach F, Schindele D, Grube C, Ricke J, Schostak M. [Irreversible electroporation: the new generation of local ablation techniques for renal cell carcinoma]. Urologe A. 2012 Dec;51(12):1728-34. doi: 10.1007/s00120-012-3038-8. German.
PMID: 23139026BACKGROUNDJiang C, Davalos RV, Bischof JC. A review of basic to clinical studies of irreversible electroporation therapy. IEEE Trans Biomed Eng. 2015 Jan;62(1):4-20. doi: 10.1109/TBME.2014.2367543.
PMID: 25389236BACKGROUNDWendler JJ, Porsch M, Fischbach F, Pech M, Schostak M, Liehr UB. Letter to the Editor Concerning "Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial" by Ricke et al. 2015 (doi:10.1007/s00270-014-1049-0). Cardiovasc Intervent Radiol. 2015 Aug;38(4):1064-5. doi: 10.1007/s00270-015-1096-1. Epub 2015 Apr 23. No abstract available.
PMID: 25902855DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Uwe- B. Liehr, Dr. med.
Department of Urology, University Magdeburg, Germany.
- STUDY DIRECTOR
Martin Schostak, Prof. Dr.
Department of Urology, University Magdeburg, Germany
- PRINCIPAL INVESTIGATOR
Johann J. Wendler, Dr. med.
Department of Urology, University Magdeburg, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. med.
Study Record Dates
First Submitted
October 15, 2013
First Posted
October 22, 2013
Study Start
October 1, 2013
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
November 19, 2014
Record last verified: 2014-11