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).

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.

Study Overview

• Status: Unknown
• Conditions: Renal Cell Cancer; Kidney Tumor
• Intervention / Treatment: Procedure: Irreversible Electroporation (IRE)

Detailed Description

Health Condition or Problem studied:

1. International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD10): C64 - Malignant neoplasm of kidney, except renal pelvis
2. ICD10: D41.0 - Neoplasm of uncertain or unknown behaviour: Kidney

Interventions/Observational Groups Arm 1:

1. Initial diagnostical examination of the renal mass.
2. If any extended diagnostical examination for treatment planning.
3. Day -29 to -1: Recruitment.
4. Day -1: MRI of the kidney, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
5. 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.
6. Day 1-7: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, life quality assessment.
7. Day 27: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
8. Day 28: Open surgery partial kidney resection or tumor nephrectomy of the IRE treated kidney resp. kidney tumor region with histopathological investigation.
9. Day 29-37: Postoperative follow-up: physical examination, blood chemistry, urosonography, life quality assessment.
10. 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.
11. 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

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22547
    • Recruiting
    • MVZ Hanse Histologikum GmbH Hamburg
    • Contact: Jens Köllermann, PD Dr. med.; Phone Number: 0049-40-707085200; Email: koellermann@pathologie-hh.de
    • Sub-Investigator: Jens Köllermann, PD Dr. med
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Recruiting
      • Department of Pathology University Hospital Otto-von-Guericke-University Magdeburg
      • Sub-Investigator: Sandra Böttcher, Dr.
      • Sub-Investigator: Albert Roessner, Prof.
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Recruiting
      • Department of Radiology University Hospital Otto-von-Guericke-University Magdeburg
      • Sub-Investigator: Jens Ricke, Prof.
      • Sub-Investigator: Frank Fischbach, Prof.
      • Sub-Investigator: Maciej Pech, Prof.
      • Sub-Investigator: Julian Jürgens
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
      • Recruiting
      • Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
      • Sub-Investigator: Markus Porsch, Dr.
      • Sub-Investigator: Andreas Janitzky, Dr.
      • Sub-Investigator: Daniel Baumunk, Dr.
      • Sub-Investigator: Daniel Schindele, Dr.
      • Sub-Investigator: Simon Blaschke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Magdeburg
• Investigators: 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

Publications and helpful links

General Publications

• 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.
• Jiang 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.
• Wendler 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.

Helpful Links

• Department of Urology, University Magdeburg

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: October 15, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Estimate): November 19, 2014
• Last Update Submitted That Met QC Criteria: November 18, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: percutaneous; ablation; kidney tumor; renal cell cancer; irreversible electroporation; IRE; RCC; partial kidney resection; IRENE
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Carcinoma, Renal Cell
• Other Study ID Numbers: DE-UKMD-URO-001; DRKS00004266 (Other Identifier: Internat. Clinical Trials Registry Platform ICTRP, WHO); U1111-1140-0415 (Other Identifier: Universal Trial Number (UTN)); EUDAMED-No.: CIV-12-04-006021 (Other Identifier: BfArM, German Federal Inst. for Drugs & Medical Devices); 00020520 (Other Identifier: DIMDI, German Inst. for Med. Documentation & Information)