JPRN-jRCTs041180038已完成2 期
The clinical study of evaluation in efficacy and safety using fluorescence imaging with indocyanine green for resected urological cancer - ICG urology
SOGA NORIHITO0 个研究点目标入组 35 人开始时间: 2019年2月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
The incidence of differences in the success rate between malignant lesions and the parenchyma with open surgery was extremely high but low that with robotic surgery. No case with prostate cancer and bladder cancer was recruited. Since no more case was expected to be recruited, thus this study was decided to quite.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 <= 85age old（—）
- 性别
- All
入选标准
- •1. the cases undergoing operation for renal cancer, prostate cancer or bladder cancer, associated with agreement of informed consent for this study, no concerned with clinical staging, historical disease and containing metastasis
- •2. Aged =<85 years
- •3.WHO performance status 0 or 1
- •4.Patients who satisfy the following criteria for the major organ function in tests performed within one month prior to enrollment
- •WBC =/under 3000/mm3
- •Plt =/over 100,000/mm3
- •Hgb =/over 8.0g/mm3
- •Ccr =/over 40ml/m
- •T-Bil =/under 2.0mg/dl
- •AST =/under 2.5xULN
- •ALT =/under 2.5x
排除标准
- •1.allergy for the preparation of iodine or allergy to this study drug
- •2.hepatic and renal dysfunction
- •3.possibility of side effect induced by dysfunction of clearance of ICG or metabolite of ICG
- •4.exclusion decided by physician
研究者
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