Follow-up study

JRCT ID: jRCTs061240074

Registered date:30/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Bladder cancer
• Date of first enrollment: 30/10/2024
• Target sample size: 20
• Study type: Interventional
• Intervention(s): 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 administered 4 hours (2-8 hours) before cystoscopy. Both groups will be observed at 3 days (-1 day to +1 day) after administration, and safety evaluation will be performed.

Outcome(s)

• Primary Outcome: Positive predictive value in white light and fluorescent observation

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Fukuhara Hideo
• Secondary Sponsor: Inoue Keiji
• Source(s) of Monetary Support: SBI Pharmaceutical Co., Ltd.