Exploratory study to evaluate efficacy, safety and fluorescent molecule infrastructure of photodynamic diagnosis for upper and lower gastrointestinal tumors using LED endoscopy system

Isomoto Hajime0 sites60 target enrollmentDecember 7, 2020

Overview

No summary available.

Registry

who.int

Start Date

December 7, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Isomoto Hajime

•1\) 18 or above years old male or female
•2\) Patients who undergo endoscopic examination (criteria 1\) or treatment (criteria 2\) for gastrointestinal tumor
•Criteria 1: Patients with (Including suspected symptoms) colitic cancer or DALM (dysplasia\-associated lesions or mass) related to inflammatory bowel disease
•Criteria 2: Patients with (Including suspected symptoms) esophageal tumor, gastric tumor, duodenal tumor or colon tumor
•3\) Patients with ECOG Performance Status 0 or 1
•4\) Patients with preserved heart, lung, liver and kidney function
•5\) Patients who received written consent from the study subject. For below the age of 20, patients who have also obtained consent from their legal representatives.

•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 from admission to 14 days postdose.
•4\) Patients with absolute contraindications to gastrointestinal 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