Oral cancer Oral cancer, 5-aminolevilinic acid, photodynamic diagnosis
Conditions
Interventions
One hour prior to biopsy and cytology, dissolve 1.5 grams of Araglio Granules in 50 mL of water and place on gauze around the lesion to allow penetration. The lesion is then observed with a camera equ
Sponsors
Satomura Kazuhito
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, positive predictive value, and negative predictive value for detection of oral cancer by comparing the results of ALA-PDD with histopathological and cytological diagnosis. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, positive predictive value, and negative predictive value for detection of oral potentially malignant disorder and precancerous lesion by comparing the results of ALA-PDD with histopathological diagnosis. Differentiation from other benign diseases. | — |
Contacts
Public ContactYusuke Takebe
Tsurumi University Dental Hospital
Outcome results
None listed