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

Phase 3

• Conditions: on-muscle invasive bladder cancer

• Registration Number: JPRN-jRCT2080222877
• Lead Sponsor: SBI Pharmaceuticals Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-09
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 <br><br>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)<br><br>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)