Efficacy and safety of Photodynamic diagnosis using aminolaevulinic acid for oral cancer patients.

Not Applicable

• Conditions: Oral cancer; Oral cancer, 5-aminolevilinic acid, photodynamic diagnosis

• Registration Number: JPRN-jRCTs031230192
• Lead Sponsor: Satomura Kazuhito

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified