Non-muscle invasive bladder cancer
Conditions
Interventions
investigational material(s)
Generic name etc : SPP-005
INN of investigational material : 5-aminolevulinic acid hydrochloride
Therapeutic category code : 729 Other diagnostic agents (except extracorpor
Sponsors
SBI Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Outcome results
None listed