Flexible fluorescence-cystoscopy in non-muscle-invasive bladder cancer

JRCT ID: jRCTs031230643

Registered date:19/02/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-muscle invasive bladder cancer
• Date of first enrollment: 04/03/2024
• Target sample size: 110
• Study type: Interventional

Intervention(s)

(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, 3 hours (range: 2 to 4 hours) before the start of surgery, 20 mg/kg of 5-ALA (Alaglio(R) granule sachet 1.5 g) dissolved in 50 cc of water was administered orally. do.
(2) Intravesical observation using a cystoscope
Observe the inside of the bladder using a cystoscope under lumbar or general anesthesia in the operating room.
Observations using a cystoscope should be performed in the order of steps 1 to 4 below.
1. white light flexible cystoscope
2. fluorescent flexible cystoscope
3. white light rigid cystoscope
4. fluorescent rigid cystoscope

Outcome(s)

• Primary Outcome: Specificity in bladder neck and trigone

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 85age old
• Gender: Both

Include 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
-Blood urea nitrogen, creatinine, total bilirubin, AST and ALT <= 1.5 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

Exclude criteria

(1) Patients whose tumor size exceeds 2 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

Related Information

• Primary Sponsor: Yoshida Soichiro
• Source(s) of Monetary Support: SBI Pharmaceuticals Co., Ltd.,Nippon Kayaku Co., Ltd.
• Secondary ID(s): Nil known