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. - IRENE

Medizinische Fakultät der Universität Magdeburg0 个研究点目标入组 10 人开始时间: 2012年7月23日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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

•- 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

发起方

Medizinische Fakultät der Universität Magdeburg