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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001337

Enrollment

165

Registered

2008-08-27

Start date

2008-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial bladder cancer

Interventions

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

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 b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patient who has primary and recurrent superficial bladder cancer indicated for transurethral biopsy of bladder mocosa (TU-biopsy) and/or transurethral resection of bladder tumor (TURBT)

Exclusion criteria

Exclusion criteria: patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction

Design outcomes

Primary

Measure	Time frame
Number of side effect by grade Incidence of side effect by grade	—

Secondary

Measure	Time frame
Diagnostic accuracy: Comparison between fluorescence guide-cystoscopy mediated by 5-ALA and histological findings of collected tissue by biopsy or TURBT	—

Countries

Japan

Contacts

Public ContactKeiji Inoue

Kochi Medical School Department of Urology, Kochi Medical School

keiji@kochi-u.ac.jp088-880-2402

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026