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: Interventional
- Study Design
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: December 2015
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.
- (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
- 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
- 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
- Time Frame: 4 month
- adverse effects Assessment of the procedural compliance Assessment of the Quality of Life (QoL)
Participating in This Clinical Trial
- 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
- 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
- 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
- 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, firstname.lastname@example.org
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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