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

Isomoto Hajime0 sites62 target enrollmentOctober 13, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 13, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Isomoto Hajime

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

•\[5ALA group]
•1\) Patients with a history of hypersensitivity to 5\-ALA or porphyrin
•2\) Porphyria patients
•3\) Patients who need to take medicines or foods known to cause photosensitivity within 48 hours after administration of study drug from admission.
•4\) Patients with absolute contraindications to endoscopy
•5\) Pregnant women or patients who may be pregnant
•6\) Patients who cannot ingest
•7\) Patients who cannot be properly shielded 48 hours postdose
•8\) Patients who received drug treatment for malignant tumor within 1 month before obtaining consent
•9\) Patients who received study drug within 3 months before study drug administration