Clinical trial · Interventional
IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.
Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).
NCT01967407CI-TRIAL-00016102IRENEunknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Tumor | Kidney Neoplasm | ALIAS | 0.90 |
| Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irreversible Electroporation (IRE) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- renal tumor <4cm, suspected RCC
- description
- Intervention/ Time point: Irreversible Electroporation at day 0 of each patient.
- interventionNames
- Procedure: Irreversible Electroporation (IRE)
Primary outcomes (1)
- measure
- 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
- timeFrame
- 28 days
- description
- onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis
Secondary outcomes (1)
- measure
- safety
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * violation against one or more inclusion criteria * 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 * 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 * MRI incompatibility * metal implants \<1 cm closed to the kidney / kidney tumor * contraindication for biopsy and punction of the renal tumor under CT-guidance * untreated urinary retention * renal pelvis tumor, suspected transitional cell cancer
References
Publications (3)
- BACKGROUNDLiehr 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 23139026
- BACKGROUNDJiang 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 25389236
- DERIVEDWendler 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 25902855