jRCT2080222877未知3 期
A Phase III of Photodynamic Diagnosis of Bladder Cancer using Fluorescence Cystoscopy with SPP-005 (5-ALA)
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 主要终点
- Sensitivity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Open Label, Multicenter, Central Registration
入排标准
- 年龄范围
- 20age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Patients with bladder cancer who will undergo TURBT
- •Understands the nature of this study and agrees to participate on their free will and is able to give a informed consent.
- •Aged between 20 and 85 years at informed consent signed
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at the time of Enrollment
- •Their laboratory test results 14 days prior to the administration is within the limit range as listed below;
- •Renal function: BUN < ULNx1.5, Serum creatinine < ULNx1.5
- •Liver function: AST(GOT) < ULNx1.5, ALT(GPT) < ULNx1.5, Serum bilirubin < ULNx1.5
- •Blood count: 1,500/mm3 < Neutrophil, 100,000/mm3 < Platelet, 8.5g/dL < Hemoglobin
- •Willing to comply with all study requirements
排除标准
- •Patients who have experienced myocardial infarction within 3 months prior to informed consent, or who have a history of, or active active angina pectoris, arrhythmia that requires treatment or cardiac failure congestive.
- •Patients with severe disease (e.g. poorly controlled hypertension or diabetes mellitu, or others )
- •Patients with interstitial pneumonia or pulmonary fibrosis
- •Patients with severe infectious disease including Tuberculous
- •Patients who are pregnant, breast-feeding or suspected of being pregnant
- •Patients who are unwilling to practice effective contraception
- •Patients with multiple primary cancer
- •Patients who have known sensitivity to porphyrins or a similar compound
- •Patients who have received bladder cancer treatment in the 6 months of informed consent
- •Patients who have participated in a clinical study within 3 months of informed consent
- •Patients who are deemed otherwise not suitable for enrolment by the Investigator
结局指标
主要结局
Sensitivity
The percentage of tumor positive lesions under fluorescence light (or tumor positive lesions under conventional white light) out of pathologically diagnosed tumor positive biopsies
次要结局
- Specificity
- Positive Predictive Value
- Negative Predictive Value
研究者
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