Feasibility study of photodynamic diagnosis using 5ALA for early head and neck or gastrointestinal cancer

Feasibility study of photodynamic diagnosis using 5ALA for early head and neck or gastrointestinal cancer - Feasibility study of 5ALA-PDD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008874

Enrollment

Registered

2012-09-07

Start date

2012-09-07

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

early head and neck or gastrointestinal cancer

Interventions

5ALA is administered orally 3 hours before EMR/ESD.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) EMR or ESD is scheduled for following i) or ii) cancer. i. Tis-T2, N0, M0 oropharynx or hypopharynx cancer ii. T1, N0, M0 esophagus, stomach ,or colon cancer 2) >= 20 years old. 3) ECOG performance status of <= 1. 4) No prior radiation for cancer in the target organ. 5) Adequate organ function. 6) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) A history of photosensitivity. 2) Porphyria. 3) Women during pregnancy or breast-feeding. 4) Cirrhosis, acute or chronic hepatitis. 5) Systemic treatment is indicated for bacterial or fungal infection. 6) Positive HBs antigen, HCV antibody or known positive serology for HIV. 7) Patient is judged to be inappropriate for study participation for any reason by the investigator.

Design outcomes

Primary

Measure	Time frame
Concordance rate between fluorescence intensity and pathological findings	—

Secondary

Measure	Time frame
Adverse events Tissue damage by laser.	—

Countries

Japan

Contacts

Public ContactTomoji Kato

National Cancer Center Hospital East Gastrointestinal Oncology Division

tomkato@east.ncc.go.jp04-7133-1111

Outcome results

None listed

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