Lung cancer
Conditions
Interventions
During a pulmonary segmentectomy, vitamin B2 is administered intravenously after the segmental branch of the pulmonary artery is dissected. During this procedure, a black light irradiator is used whil
Sponsors
Shien Kazuhiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have been fully informed of the contents of this study and have given written consent 2. Patients who are 18 years of age or older at the time of consent 3. Patients who are scheduled to undergo a lung resection for lung cancer or suspected lung cancer
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal renal function (eGFR < 40 mL/min/1.73 m2) 2. Patients with abnormal liver function (AST [GOT] or ALT [GPT] more than twice the institutional standard) 3. Patients with a history of iodine allergy 4. Patients with severe emphysema or interstitial pneumonia on preoperative CT scan and considered difficult to identify the intersegmental plane by ICG fluorescence method 5. Patients who are taking vitamin B2-containing supplements and cannot discontinue them for 1 day before surgery 6. Pregnant women, lactating women, patients with a positive pregnancy test, or patients who do not intend to use contraception 7. Patients who are inappropriate for this study judged by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Incidence of dose limiting toxicity (DLT) in each dose group Phase II: Intersegment identification rate of vitamin B2 method at the recommended dose (RD) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intersegment identicication rate to the total intersegmental plane for each case (vitamin B2 and ICG fluorescence methods) 2. Intersegmental concordance rate and percentage as determined by ICG fluorescence and vitamin B2 methods 3. Surgical outcomes (operation time, duration of postoperative thoracic drainage, postoperative complication rate, postoperative hospital stay, and complete resection rate) 4. Safety of the vitamin B2 method | — |
Contacts
Public ContactKazuhiko Shien
Okayama University Hospital
Outcome results
None listed