IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy. — IRENE  

Renal Cell Cancer Clinical Trial

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).

Status Recruiting

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.

Clinical Trial 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 ;

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

• NCT number: NCT01967407
• Study type: Interventional
• Source: University of Magdeburg
• Contact: Antje Wiede, Dr.
• Phone: +493916721841
• Email: antje.wiede@med.ovgu.de
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: October 2013
• Completion date: January 2016