Bladder cancer Urology, Bladder, Cancer
Conditions
Interventions
Cystoscopy using photodynamic diagnosis with administration of aminolevulinic acid hydrochloride (5-ALA). Participants will be assigned according to the dose (10mg/kg and 20mg/kg). 5-ALA will be admin
Sponsors
Fukuhara Hideo
Inoue Keiji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be included in this study. (1) Age between 20 and 90 years old on the day of consent (regardless of gender) (2) Patients who were diagnosed with bladder cancer and underwent PDD-TURBT before the day of consent (3) Patients who are undergoing outpatient follow-up and who are scheduled for outpatient cystoscopy and deemed necessary (4) Patients who are deemed eligible for PDD-TURBT if recurrence is suspected during outpatient cystoscopy (5) Patients who can comply with the protocol regulations, such as the designated visit dates (6) Patients who have given their own voluntary written consent to participate in this study (7) Patients who have been informed of their disease name and condition
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will not be enrolled in this study. (1) Patients with a history of hypersensitivity to 5-ALA or porphyrin (2) Patients with porphyria (3) Patients with a history of hypotension caused by 5-ALA in a previous PDD-TURBT (4) Patients with severe cardiovascular disease (5) Patients with severe liver dysfunction (bilirubin: >=3 times the upper limit of normal at the institution, Gamma-GTP: >=5 times the upper limit of normal at the institution, ALT/AST: >=5 times the upper limit of normal at the institution) (6) Patients with severe renal dysfunction (creatinine: >=2 times the upper limit of normal at the institution) (7) Female patients who are pregnant, breastfeeding, or possibly pregnant (8) Patients who have participated in other clinical trials or interventional clinical studies within 3 months of the date of consent acquisition (9) Patients who are otherwise deemed inappropriate for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive predictive value in white light and fluorescent observation | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Positive predictive value in the 10mg/kg and 20mg/kg groups (2) Proportion of positive subjects to total study subjects (3) Adverse events and their occurrence rates in the 10 mg/kg and 20 mg/kg groups | — |
Contacts
Public ContactHideo Fukuhara
Kochi Medical School Hospital
Outcome results
None listed