Photodynamic diagnosis by LED endoscopy system

JRCT ID: jRCTs061200034

Registered date:07/12/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alimentary canal tumor
• Date of first enrollment: 07/12/2020
• Target sample size: 60
• Study type: Interventional
• Intervention(s): Aminolevulinic acid hydrochloride administration, non-approved endoscope system usage

Outcome(s)

• Primary Outcome: Detection rate of alimentary canal tumor by LED photodynamic endoscopic diagnosis with 5-ALA

Secondary Outcome

1) Detection sensitivity, specificity, positive rate and negative rate of alimentary canal tumor in LED photodynamic endoscopic diagnosis with 5-ALA
2) Advesed event
3) PpIX specific fluorescence spectrum measured by a spectroscope in LED photodynamic endoscopic diagnosis with 5-ALA for alimentary canal tumor
4) Correlation between LED photodynamic endoscopic diagnosis with 5-ALA for alimentary canal tumor and PpIX intrinsic fluorescence spectrum measured by spectroscope, clinicopathologic features, magnifying endoscope findings
5) Correlation between activity or expression of related molecules and fluorescence in LED photodynamic endoscopic diagnosis with 5-ALA for alimentary canal tumor
6) Detectability of multiple synchronous lesions by LED photodynamic endoscopic diagnosis with 5-ALA

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Isomoto Hajime
• Source(s) of Monetary Support: FUJIFILM