Exploratory study to evaluate the detection ability of photodynamic endoscopic imaging for differentiated gastric cancer and gastric adenoma

Phase 2

Recruiting

• Conditions: gastric cancer, gastric adenoma

• Registration Number: JPRN-jRCTs061230040
• Lead Sponsor: Isomoto Hajime

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-26
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

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

Inclusion Criteria

1) Patients scheduled for endoscopic resection of differentiated gastric cancer or gastric adenoma in the stomach after HP infection or eradication
2) Patients of over 18 years at the time of consent
3) Patients with ECOG Performance Status 0 or 1
4) Patients with preserved function of major organs such as heart, lungs, liver, and kidney. In particul
ar, the liver, kidneys, and blood coagulation capacity must meet the following criteria based on blood tests at screening.
-Liver: bilirubin < upper limit of normal range (ULN) * 1.5, ALT < ULN * 3, AST < ULN * 3; bilirubin < ULN * 3 if Gilbert's syndrome is suspected
-Kidney: creatinine 45ml/min
-Blood coagulability: PT INR and APTT values judged acceptable by the study investigator to undergo endoscopic examination.
5) Females of reproductive potential and males who are willing to use a highly effective contracepti
ve method (Pearl index <1) during the study period.
(6) Patients who have given free and voluntary written consent to the study

Exclusion Criteria

1) Patients with a history of gastric surgery
2) Patients scheduled on endoscopic resection for recurrence after endoscopic treatment
3) Patients with active cancer of other organs
4) Patients with hypersensitivity to porphyrin analogues
5) Patients with a history of photosensitivity
6) Patients with serious infections
7) Patients with contraindications to gastrointestinal endoscopy
8) Pregnant or lactating women, or women of childbearing potential
9) Other patients deemed ineligible by the principal investigator or subinvestigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified