NCT01967407Unknown1 期
Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).
University of Magdeburg8 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 8
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
Health Condition or Problem studied:
- International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD10): C64 - Malignant neoplasm of kidney, except renal pelvis
- ICD10: D41.0 - Neoplasm of uncertain or unknown behaviour: Kidney
Interventions/Observational Groups Arm 1:
- Initial diagnostical examination of the renal mass.
- If any extended diagnostical examination for treatment planning.
- Day -29 to -1: Recruitment.
- Day -1: MRI of the kidney, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
- 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.
- Day 1-7: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, life quality assessment.
- Day 27: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
- Day 28: Open surgery partial kidney resection or tumor nephrectomy of the IRE treated kidney resp. kidney tumor region with histopathological investigation.
- Day 29-37: Postoperative follow-up: physical examination, blood chemistry, urosonography, life quality assessment.
- 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.
- Study closed, Individual follow-up due to the European Association of Urology guideline.
Recruitment:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 28 days
onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis
次要结局
- safety(4 month)
研究者
Johann J. Wendler, MD
Dr. med.
University of Magdeburg
研究点 (8)
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