Clinical trial NCT01967407: IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.
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).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Kidney Tumor
Renal Cell Cancer
Keywords: kidney tumor
renal cell cancer
RCC
irreversible electroporation
IRE
partial kidney resection
percutaneous
ablation
IRENE
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2013-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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: 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 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
* 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

Primary outcomes:
measure: 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
timeFrame: 28 days
Secondary outcomes:
measure: safety
timeFrame: 4 month
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Department of Pathology University Hospital Otto-von-Guericke-University Magdeburg
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Department of Radiology University Hospital Otto-von-Guericke-University Magdeburg
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
state: Sachsen-Anhalt
city: Hamburg
country: Germany
facility: MVZ Hanse Histologikum GmbH Hamburg
Study officials:
affiliation: Department of Urology, University Magdeburg, Germany.
name: Uwe- B. Liehr, Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Urology, University Magdeburg, Germany
name: Martin Schostak, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Department of Urology, University Magdeburg, Germany
name: Johann J. Wendler, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.