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

Feasibility study of in vivo photodynamic diagnosis using 5ALA for head and neck or gastrointestinal cancer - 5ALAPDD invivo

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013791

Enrollment

Registered

2014-05-12

Start date

2014-05-19

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

Head and neck or Gastrointestinal cancer

Interventions

To perform photodynamic diagnosis 4-6 hours later after oral administration of 5ALA

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Tis-T1, oropharynx or hypopharynx cancer, esophageal cancer, gastric cancer, colon cancer. 2)=> 20 years old 3)Performance status (ECOG) 0 or 1 4)Adequate organ function 5)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Photosensitivity 2)Porphyria 3)pregnant or nursing women 4)Liver cirrhosis, acute or chronic hepatitis 5)Active bacterial or fungal infection requiring systemic medication 6)Positive HBs antigen, HCV antibody or known positive serology for HIV 7)Patient is judged to be inappropriate for study enrollment by investigator

Design outcomes

Primary

Measure	Time frame
Concordance rate between Fluorescence intensity and pathological results	—

Secondary

Measure	Time frame
Adverse event and PpIX level in biopsy specimensand plasma	—

Countries

Japan

Contacts

Public ContactAkihiro Sato

National Cancer Center Exploratory Oncology Research &Clinical Trial Center Clinical trial section

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

Outcome results

None listed

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