IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.

Study Overview
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Brief Summary
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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.

Detailed Description
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Health Condition or Problem studied: International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD10): C64 - Malignant neoplasm of kidney, except renal pelvis ICD10: D41.0 - Neoplasm of uncertain or unknown behaviour: Kidney Interventions/Observational Groups Arm 1: Initial diagnostical examination of the renal mass. If any extended diagnostical examination for treatment planning. Day -29 to -1: Recruitment. Day -1: MRI of the kidney, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. Day 0: Percutaneous diagnostical biopsy with histopathological investigation and therapeutically, CT- and/or ultrasound-guided, ECG-synchronized irreversible electroporation (IRE) of the kidney tumor in endotracheal anaesthesia und muscle relaxation. Use of 1-6 IRE probes with 90-100 pulses of 1500-3000 volts und 20-50 amperes each. Day 1-7: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, life quality assessment. Day 27: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. Day 28: Open surgery partial kidney resection or tumor nephrectomy of the IRE treated kidney resp. kidney tumor region with histopathological investigation. Day 29-37: Postoperative follow-up: physical examination, blood chemistry, urosonography, life quality assessment. Day 112: Study-Follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. Termination of the study. Study closed, Individual follow-up due to the European Association of Urology guideline. Recruitment: (Anticipated or Actual) Date of First Enrollment: 2013/10/14 Planned/Actual: Opened Target Sample Size: 20 Monocentric/Multicentric trial: Monocentric trial National/International: National

Official Title
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Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).

Conditions
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Kidney Tumor, Renal Cell Cancer

Intervention / Treatment
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* Procedure: Irreversible Electroporation (IRE)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: renal tumor <4cm, suspected RCC<br>Intervention/ Time point: Irreversible Electroporation at day 0 of each patient. | Procedure: Irreversible Electroporation (IRE)<br>* Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.<br>* Other names: NanoKnife (Tissue Ablation) System, AngioDynamics Inc.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | adverse effects Assessment of the procedural compliance Assessment of the Quality of Life (QoL) | 4 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney tumor, renal cell cancer, RCC, irreversible electroporation, IRE, partial kidney resection, percutaneous, ablation, IRENE