A Phase III of Photodynamic Diagnosis of Bladder Cancer using Fluorescence Cystoscopy with SPP-005 (5-ALA)

SBI Pharmaceuticals Co., Ltd.0 个研究点目标入组 60 人开始时间: 2015年6月9日最近更新: 2023年10月17日

适应症

试验速览

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•1) Patients with bladder cancer who will undergo TURBT
•2) Understands the nature of this study and agrees to participate on their free will and is able to give a informed consent.
•3) Aged between 20 and 85 years at informed consent signed
•4) Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 at the time of Enrollment
•5) 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
•6) Willing to comply with all study requirements

•1) 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.
•2) Patients with severe disease (e.g. poorly controlled hypertension or diabetes mellitu, or others )
•3) Patients with interstitial pneumonia or pulmonary fibrosis
•4) Patients with severe infectious disease including Tuberculous
•5) Patients who are pregnant, breast-feeding or suspected of being pregnant
•6) Patients who are unwilling to practice effective contraception
•7) Patients with multiple primary cancer
•8) Patients who have known sensitivity to porphyrins or a similar compound
•9) Patients who have received bladder cancer treatment in the 6 months of informed consent
•10) Patients who have participated in a clinical study within 3 months of informed consent
•11) Patients who are deemed otherwise not suitable for enrolment by the Investigator

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