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临床试验/JPRN-UMIN000009569
JPRN-UMIN000009569已完成未知

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

ational Cancer Center Hospital0 个研究点目标入组 160 人开始时间: 2012年12月17日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
160

研究概览

简要总结

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.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 85years-old(—)
性别
All

入选标准

  • 未提供

排除标准

  • 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.

研究者

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