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Evaluation on the detection of gastrointestinal tumors after oral administration of aminolevulinic acid-a pilot study

Evaluation on the detection of gastrointestinal tumors after oral administration of aminolevulinic acid-a pilot study - Evaluation on the detection of gastrointestinal tumors after oral administration of ALA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000009569
Enrollment
160
Registered
2012-12-17
Start date
2012-12-17
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 tumors

Interventions

ALA (10-20mg/kg) is administered orally 3-4 hours before endoscopy. Using a fluorescence detection system with violet laser diode (VLD-EX)

Sponsors

National Cancer Center Hospital
Lead Sponsor
The Jikei University School of Medicine
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) =>20 years old, <=85 years old. 2) Treatment is scheduled for the lesion. Without distinction the size. 3) Adapted estimated depth for endoscopic treatment case. 4) Endoscopic treatments are including EMR, hybrid EMR, ESD, EMRC, etc. Excluding ablation. 5) Within 60 days of study initiation. WBC => 3,500/mm3 Hb => 8.5 g/dl Plt => 100,000/mm3 T-bil <= 1.5 mg/dl AST (GOT) <= 100 IU/l ALT (GPT) <= 100 IU/l Cr <= 1.2mg/dl 7) Written informed consent.

Exclusion criteria

Exclusion criteria: 1) Patients who can not intake oral medicine. 2) A history of photosensitivity. 3) Porphyria. 4) With malignant hypertension and severe congestive heart failure. Past history of myocardial infraction within the last three months. 5) Poor control of diabetes mellitus. 6) With severe pulmonary fibrosis and acute interstitial pneumonia. 7) Poor control of infection. 8) Patient taking anticoagulants and antiplatelet agents. 9) Patient receiving ferrotherapy. 10) Participating in the study of other division. 11) Patient who is difficult to understand the informed consent. 12) Woman during pregnancy or breast-feeding. 13) Patient is judged to be inappropriate for study participation for any reason by the investigator.

Design outcomes

Primary

MeasureTime frame
Detection and visibility of gastrointestinal tumors after oral administration of ALA

Countries

Japan

Contacts

Public ContactEriko So

National Cancer Center Hospital Endoscopy division

esou@ncc.go.jp03-3542-2511

Outcome results

None listed

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