Non-muscle invasive bladder cancer
Conditions
Interventions
(1)5-ALA administration
As a general rule, patients are admitted to the hospital the day before TURBT, as in regular medical treatment.
On the day of TURBT, 2-8 hours before the start of surgery, 20 m
Sponsors
Yoshida Soichiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients scheduled for TURBT for a clinical diagnosis of NMIBC (2) Patients over 20 years old and older and under 85 years old (3) Patients with ECOG-PS 0 or 1 (4) Patients who meet the criteria for the following clinical test reference values -Absolute neutrophil count >= 1,500,000,000/L -Platelet count >= 100,000,000,000/L -Hemoglobin >= 8.5g/dL -creatinine, total bilirubin, AST and ALT <= 1.5 times ULN -Blood urea nitrogen <= 2 times ULN (5) Patients who are willing and able to follow the study protocol, including study visits and tests. (6) Patients who have fully understood the content of this study and have provided written consent
Exclusion criteria
Exclusion criteria: (1) Patients whose tumor size exceeds 3 cm (2) Patients with a history of cardiovascular disease (3) Patients with serious complications (uncontrolled hypertension or diabetes) (4) Patients with interstitial pneumonia or pulmonary fibrosis (5) Women who are or may become pregnant or breastfeeding (6) Patients with porphyrias and current or past hypersensitivity to porphyrins (7) Patients judged to be ineligible by the investigator for medical, psychological, or other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specificity in bladder neck and trigone | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity in the bladder neck and trigone Specificity in areas other than the bladder neck and trigone Sensitivity outside the bladder neck and trigone Percentage of research subjects for whom sufficient PDD observation was not possible | — |
Contacts
Public ContactSoichiro Yoshida
Institute of Science Tokyo Hospital
Outcome results
None listed