IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy. (IRENE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Magdeburg
Sponsor:
Information provided by (Responsible Party):
Johann Wendler, University of Magdeburg
ClinicalTrials.gov Identifier:
NCT01967407
First received: October 15, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Kidney Tumor
Renal Cell Cancer
Procedure: Irreversible Electroporation (IRE)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).

Resource links provided by NLM:


Further study details as provided by University of Magdeburg:

Primary Outcome Measures:
  • 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 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis


Secondary Outcome Measures:
  • safety [ Time Frame: 4 month ] [ Designated as safety issue: Yes ]
    • adverse effects
    • Assessment of the procedural compliance
    • Assessment of the Quality of Life (QoL)


Estimated Enrollment: 20
Study Start Date: October 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: NanoKnife (Tissue Ablation) System, AngioDynamics Inc.

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • cardial ejection fraction < 30%
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967407

Contacts
Contact: Antje Wiede, Dr. +493916721841 antje.wiede@med.ovgu.de
Contact: Johann J. Wendler, Dr. med. +493916715036 johann.wendler@med.ovgu.de

Locations
Germany
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Sub-Investigator: Markus Porsch, Dr.         
Sub-Investigator: Andreas Janitzky, Dr.         
Sub-Investigator: Daniel Baumunk, Dr.         
Sub-Investigator: Daniel Schindele, Dr.         
Sub-Investigator: Simon Blaschke         
Department of Radiology University Hospital Otto-von-Guericke-University Magdeburg Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Sub-Investigator: Jens Ricke, Prof.         
Sub-Investigator: Frank Fischbach, Prof.         
Sub-Investigator: Maciej Pech, Prof.         
Sub-Investigator: Julian Jürgens         
Department of Pathology University Hospital Otto-von-Guericke-University Magdeburg Recruiting
Magdeburg, Sachsen-Anhalt, Germany, 39120
Sub-Investigator: Sandra Böttcher, Dr.         
Sub-Investigator: Albert Roessner, Prof.         
Sponsors and Collaborators
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
  More Information

Additional Information:
Publications:
Responsible Party: Johann Wendler, Dr. med., University of Magdeburg
ClinicalTrials.gov Identifier: NCT01967407     History of Changes
Other Study ID Numbers: DE-UKMD-URO-001, DRKS00004266, U1111-1140-0415, DRKS00004266, EUDAMED-No.: CIV-12-04-006021, 00020520
Study First Received: October 15, 2013
Last Updated: October 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: German Institute of Medical Documentation and Information

Keywords provided by University of Magdeburg:
kidney tumor
renal cell cancer
RCC
irreversible electroporation
IRE
partial kidney resection
percutaneous
ablation
IRENE

Additional relevant MeSH terms:
Kidney Neoplasms
Neoplasms
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014