A Phase III of Photodynamic Diagnosis of Bladder Cancer using Fluorescence Cystoscopy with SPP-005 (5-ALA)
version:
date:
SBI Pharmaceuticals Co., Ltd.
+81-3-6229-0095
60
Interventional
Open Label, Multicenter, Central Registration
3
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
20age old over
85age old under
Both
Non-muscle invasive bladder cancer
investigational material(s)
Generic name etc : SPP-005
INN of investigational material : 5-aminolevulinic acid hydrochloride
Therapeutic category code : 729 Other diagnostic agents (except extracorporeal diagnostic medicines)
Dosage and Administration for Investigational material : Oral administration of SPP-005 at a dosage of 20mg/kg
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
1) Specificity: The percentage of tumor negative lesions under fluorescence light (or tumor negative lesions under conventional white light) out of pathologically diagnosed tumor negative biopsies
2) Positive Predictive Value: The percentage of pathologically diagnosed tumor positive biopsies out of tumor positive lesions under fluorescence light (or tumor positive lesions under conventional white light)
3) Negative Predictive Value: The percentage of pathologically diagnosed tumor negative biopsies out of tumor negative lesions under fluorescence light (or tumor negative lesions under conventional white light)
