IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.

Renal Cell Cancer Clinical Trial

— IRENE  

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).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01967407
• Other study ID #: DE-UKMD-URO-001
• Secondary ID: DRKS00004266U111
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: October 15, 2013
• Last updated: November 18, 2014
• Start date: October 2013
• Est. completion date: January 2016

Study information

• Verified date: November 2014
• Source: University of Magdeburg
• Contact: Antje Wiede, Dr.
• Phone: +493916721841
• Email: antje.wiede[@]med.ovgu.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Kidney Tumor
• Renal Cell Cancer

Intervention

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

Locations

Country	Name	City	State
Germany	MVZ Hanse Histologikum GmbH Hamburg	Hamburg
Germany	Department of Pathology University Hospital Otto-von-Guericke-University Magdeburg	Magdeburg	Sachsen-Anhalt
Germany	Department of Radiology University Hospital Otto-von-Guericke-University Magdeburg	Magdeburg	Sachsen-Anhalt
Germany	Department of Urology University Hospital Otto-von-Guericke-University Magdeburg	Magdeburg	Sachsen-Anhalt

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	safety	adverse effects; Assessment of the procedural compliance; Assessment of the Quality of Life (QoL)	4 month	Yes

External Links

•   Department of Urology, University Magdeburg
•   German Clinical Trials Register (DRKS)