Photodynamic diagnosis of bladder cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)

UMIN ID: UMIN000001337

Registered date:27/08/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Superficial bladder cancer
• Date of first enrollment: 2008/01/01
• Target sample size: 165
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): 5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50mL of 5% glucose solution. 5-ALA solution was administered either way of following: Orally(1.0g/50mL); 180-240minutes before operation Instilled intravesically(1.5g/50mL); 90-120 minutes before operation. For fluorescence excitation a blue light source (D-LIGHT System, Karl Storz Endoscopy Japan K.K.) was used. Under white and fluorescence light guidance outputted by light source apparatus (D-Light AF System) and videocamera system (Endovision TELECAM SL/IPM-PPD System), tumor locations were recorded, cold cup biopsies were taken and tumors were resected.

Outcome(s)

• Primary Outcome: Number of side effect by grade Incidence of side effect by grade
• Secondary Outcome: Diagnostic accuracy: Comparison between fluorescence guide-cystoscopy mediated by 5-ALA and histological findings of collected tissue by biopsy or TURBT

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction

Related Information

• Primary Sponsor: Department of Urology, Kochi Medical School
• Secondary Sponsor: Ethical committee, Kochi Medical School
• Source(s) of Monetary Support: None,Kohasu, Oko, Nankoku, Kochi, Japan