esophageal cancer (squamous cell carcinoma)
Conditions
Sponsors
Tsuji Yosuke
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Patients or legal representative who provide a signed document of informed consent for participation in the study 2.Patients who are able to understand and comply with the contents of this clinical trial 3.Patients who are male 4.Patients aged 18 years or older at the time of informed consent 5.Patients histologically diagnosed as esophageal cancer (squamous cell carcinoma) and judged to be suitable for endoscopic treatment based on Guidelines for Diagnosis and Treatment of Carcinoma of the Esophagus (2022 edition) 6.Patients who can be contraceptive using condoms and other contraceptive methods for 3 months after administration of investigational products
Exclusion criteria
Exclusion criteria: 1. Patients aged 85 years or older 2. Patients with the following serious complications A) Patients with infections that require systemic treatment B) Patients who are being treated with continuous use of insulin or who have uncontrollable diabetes C) Patients with uncontrollable hypertension D) Patients with unstable angina or a history of myocardial infarction within 6 months E) Patients with uncontrollable congestive heart failure or arrhythmia F) Patients who have pulmonary fibrosis and/or Interstitial pneumonia, whose complications or history of both diseases G) Patients who have difficulty in controlling bowel movements such as watery stool or chronic constipation H) Patients with hemorrhagic peptic ulcer, intestinal palsy, intestinal obstruction I) Patients with gastrointestinal dysfunction or gastrointestinal liseases except esophageal cancer J) Patients with acute kidney injury or uncontrolled kidney disease K) Patients who have psychosis or psychiatric symptoms and are considered difficult to participate in this trial 3. Patients who received other investigational products within 3 months before the screening examination 4. Patients with a history of hypersensitivity to the ingredients of this drug and investigational drug 5. Patients who are planning to use a DPP-4 inhibitor within 28 days before administration of the study drug 6. Patients who the principal Investigator considers not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The performance (sensitivity, specificity, positive predictive value, negative predictive value, accuracy) of fluorescence diagnosis will be evaluated using pathological test results as a definitive diagnosis for specimens collected from the most fluorescent region and the non-fluorescent region in the vicinity of the region targeted for endoscopic treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| The performance of fluorescence diagnosis will be evaluated using pathological test results as a definitive diagnosis for newly discovered fluorescent sites outside the target area of endoscopic treatment. | — |
Contacts
Public Contactresponsible party Development department
GORYO Chemical, Inc.
Outcome results
None listed