IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2015

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

Interventions

  • Procedure: Irreversible Electroporation (IRE)
    • Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.

Arms, Groups and Cohorts

  • Experimental: renal tumor <4cm, suspected RCC
    • Intervention/ Time point: Irreversible Electroporation at day 0 of each patient.

Clinical Trial Outcome Measures

Primary 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
    • onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis

Secondary Measures

  • safety
    • Time Frame: 4 month
    • adverse effects Assessment of the procedural compliance Assessment of the Quality of Life (QoL)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Magdeburg
  • Provider of Information About this Clinical Study
    • Principal Investigator: Johann J. Wendler, MD, Dr. med. – University of Magdeburg
  • Overall Official(s)
    • Uwe- B. Liehr, Dr. med., Principal Investigator, Department of Urology, University Magdeburg, Germany.
    • Martin Schostak, Prof. Dr., Study Director, Department of Urology, University Magdeburg, Germany
    • Johann J. Wendler, Dr. med., Principal Investigator, Department of Urology, University Magdeburg, Germany
  • Overall Contact(s)
    • Antje Wiede, Dr., +493916721841, antje.wiede@med.ovgu.de

References

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. Review.

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