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

JRCT ID: jRCTs061230040

Registered date:26/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: gastric cancer, gastric adenoma
• Date of first enrollment: 31/08/2023
• Target sample size: 80
• Study type: Interventional
• Intervention(s): Study drug administration, endoscopy

Outcome(s)

• Primary Outcome: Detection rate of fluorescence with 5-ALA-PEI for lesions already noted

Secondary Outcome

1) Number of lesions newly detected by 5-ALA-PEI alone and its frequency in relation to the total number of lesions
2) Diagnostic performance (sensitivity, specificity, positive predictive value, negative predictive value, false positive value, and false negative value) of 5-ALA-PEI for lesions newly detected in this study
3) Detection rate of fluorescence by 5-ALA-PEI in all lesions
4) Difference in detection rate of 5-ALA-PEI when all lesions are divided into those currently infected with Helicobacter pylori and those after Helicobacter pylori eradication
5) Verification of the relationship between fluores cence intensity (strong positive/weak positive/neg ative) and histopathological type
6) Concordance rate of fluorescence diagnosis between 5-ALA-PEI performing physicians and central judgment committee members
7) Adverse events

Key inclusion & exclusion criteria

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

Include 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 <ULN*3, eGFR>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

Exclude 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

Related Information

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