JPRN-jRCTs061230040
Recruiting
Phase 2
An exploratory study to evaluate the detection ability of photodynamic endoscopic imaging for differentiated gastric cancer and gastric adenoma in patients with current or past Helicobacter.pylori infection: a multicenter in terventional study
Isomoto Hajime0 sites80 target enrollmentJuly 26, 2023
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Isomoto Hajime
- Enrollment
- 80
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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
Outcomes
Primary Outcomes
Not specified
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