C64 D41.0
Conditions
Interventions
Group 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 kidneys, ECG, p
Sponsors
Medizinische Fakultät
der Universität Magdeburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion 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% and ECOG = 1 - Age = 18 Jahre - life expectancy = 12 month - compliance of the patient taking part in a study - informed consent
Exclusion criteria
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1) Procedural compatibility of IRE and the following tumor area resection. 2) Side effects of percutaneous IRE of localized renal tumors. 3) Life quality after IRE (EORTC CQLQ-30, VAS). 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. | — |
Countries
Germany
Contacts
Public ContactSimone Nitschke
Universitätsklinik für Urologie und Kinderurologie Universitätsklinikum Magdeburg A.ö.R.
Outcome results
None listed