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临床试验/NCT02012036
NCT02012036已完成不适用

OPTIC-III Prospective Non-Interventional Study To Optimize Photodynamic TUR-B In Clinical Practice

Ipsen2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2013年7月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Ipsen
入组人数
400
试验地点
2
主要终点
Detection rate
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to assess additional detection of Non-Muscle-Invasive Bladder Cancer (NMIBC) with hexyl aminolevulinate (HAL) cystoscopy based on lesions in patients undergoing TUR-B compared to white-light cystoscopy under the conditions of daily clinical practice.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • •Indication of TURB due to suspicion of NMIBC (patients suspected to have non muscle invasive bladder cancer).
  • •Subject able to comply with the protocol.
  • •Written informed consent available.

排除标准

  • •Hypersensitivity to the active substance or to any of the excipients of the solvent.
  • •Porphyria.
  • •Gross haematuria.
  • •Women of child-bearing potential.
  • •Repeated TURB (control TURB) as part of follow-up after previous TURB.
  • •Bacillus Calmette-Guerin (BCG) or Mitomycin / intravesical chemotherapy instillation therapy in the last 12 weeks or any other contraindications according to the SmPC.
  • •Subjects not able to give informed consent.

研究组 & 干预措施

TUR-B

TUR-B in patients suspected to have non-muscle-invasive bladder cancer (NMIBC).

干预措施: Hexvix (Drug)

结局指标

主要结局

Detection rate

时间窗: At TUR-B visit, up to 1 year

Detection rate is defined as number of lesions detected or not (Detection by HAL cystoscopy compared to white light cystoscopy confirmed by histology).

次要结局

  • Detection rate for risk groups according to the European Organisation for Research and Treatment of Cancer (EORTC)-score(At TUR-B visit, up to 1 year)
  • Evaluation of the diagnostic procedure in practice and compared to procedures according to published recommendations(At TUR-B visit, up to 1 year)

研究者

发起方
Ipsen
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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