Clinical study to evaluate efficacy and safety of photodynamic diagnosis using 5-ALA for oral cancer.

Satomura Kazuhito0 sites80 target enrollmentJune 30, 2023

Overview

No summary available.

Registry

who.int

Start Date

June 30, 2023

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Satomura Kazuhito

•1\) 20 or above years old male or female
•2\) Patients who require cytological and pathological diagnosis in usual care as a detailed examination of oral cancer
•3\) Patients who agree to administer 5\-ALA as a study subject
•4\) Patients with preserved heart, lung, liver and kidney function
•5\) Patients who received written consent from the study subject

•1\) Patients with a history of hypersensitivity to 5\-ALA or porphyrins
•2\) Patients with porphyria
•(3\) Patients who need to administer or ingest drugs known to cause photosensitivity during the 14 days after administration of the study drug
•or other drugs known to cause photosensitivity during the first 14 days after administration of the study drug
•(4\) Patients with systolic blood pressure less than 80 mmHg or diastolic blood pressure less than 40 mmHg
•(5\) Pregnant women or patients who may be pregnant
•(6\) Patients receiving drug treatment for malignancy within 1 month prior to obtaining consent
•7\) Patients who have received an investigational drug or other research drug within 3 months prior to administration of the research drug
•8\) Other patients who are judged by the principal investigator or the investigator to be inappropriate for the safe conduct of this study.