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

Not Applicable
Conditions
Gastrointestinal tumors
Registration Number
JPRN-UMIN000009569
Lead Sponsor
ational Cancer Center Hospital
Brief Summary

Twenty-three patients with a total of 27 known colorectal lesions were enrolled in the study. Eleven of the lesions were flat or depressed lesions and 16 were sessile. Red fluorescence was observed in 22 out of 27 lesions. Red fluorescence was negative in 4 out of 11 flat or depressed lesions.In comparison with histopathologic findings, the rates of red fluorescence visibility were 62.5% in low-grade intraepithelial neoplasia, 77.8% in high-grade neoplasia, and 100% in submucosal carcinoma. Red fluorescence visibility increased with the degree of dysplasia. There were no significant adverse events identified in this study.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
160
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Detection and visibility of gastrointestinal tumors after oral administration of ALA
Secondary Outcome Measures
NameTimeMethod
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