Prospective, monocentric, clinical phase-I/II study of the effectivness of the percutaneous irrversible electropration (IRE) of locally confined kidney tumors (renal cell carcinomas) - IRENE.

Not Applicable

• Conditions: C64; D41.0; Malignant neoplasm of kidney, except renal pelvis; Kidney

• Registration Number: DRKS00004266
• Lead Sponsor: Medizinische Fakultät der Universität Magdeburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-23
• Results First Posted: 2016-02-17
• Study Completion: 2018-01-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 10

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% and ECOG = 1
- Age = 18 Jahre
- life expectancy = 12 month
- compliance of the patient taking part in a study
- informed consent

Exclusion Criteria

- violation against one or more inclusion criterias
- cardial pacemaker or other electrical implants
- QT-intervall >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
- known cardial ejection fraction < 30% or NYHA 3-4
- known epilepsy
- second malignancy (except basal-cell carcinoma and cerival carcinoma in situ)
- immunesuppression or HIV-positive patients
- active infection or severe health interference, that make taking part in a study unfeasible
- pregnancy, laction 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
- generell 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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment effectivness of the irreversible electroporation (IRE) with regard to rate of persisting active tumor tissue in the histopathological and radiological examination 4 weeks after IRE.

Secondary Outcome Measures

Name	Time	Method
1) Procedural compatibility of IRE and the following tumor area resection.<br>2) Side effects of percutaneous IRE of localized renal tumors.<br>3) Life quality after IRE (EORTC CQLQ-30, VAS).<br><br>Observationtime (day -1 to day +102). Follow-up after IRE of the kidney tumor = 16 weeks = 4 month. Follow-up after partial or total kidney resection = 11 weeks = 3 month.