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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009217

Enrollment

Registered

2012-10-29

Start date

2012-10-30

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

Gastrointestinal cancer

Interventions

Two to two and half hours prior to endoscopy 1.5g 5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50ml of 8.4% sodium hydrogen carbonate (NaHCO3) so

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patient who has primary and recurrent cancer of esophagus, stomach, colorectum, pancreas, liver, gallbladder and biliary tract.

Exclusion criteria

Exclusion criteria: Patients 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
Diagnostic accuracy: The levels in images of the 5-ALA-induced fluorescence were compared with the pathological results. The diagnostic capability of photodynamic diagnosis (PDD) using fluorescence (blue light) endoscopy was compared to that in conventional diagnostic method.	—

Secondary

Measure	Time frame
Safety: The occurrence frequency and degree of adverse event were investigated through the procedures.	—

Countries

Japan

Contacts

Public ContactTsutomu Namikawa

Kochi Medical School Department of Surgery, Kochi Medical School

tsutomun@kochi-u.ac.jp+81-88-880-2370

Outcome results

None listed

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