Efficacy and Safety of a Single Dose of LS301-IT for Fluorescence Intraoperative Molecular Imaging (IMI) for Patients Undergoing Lung Cancer Resection for Non Small Cell Lung Cancer

Más betegség

• Contraindications for surgery or any medical condition that in the opinion of the investigator could jeopardize the safety of the subject
• History of any drug-related hypersensitivity or anaphylactic reactions, including those attributed to indocyanine green (ICG) or other contrast agents.
• History, or presence in the ECG at Screening, of any clinically significant abnormalities including cardiac conduction abnormalities
• History of radiation therapy to the chest

Laborértékek

• Total bilirubin level >1.5 times upper limit
• Aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) > 2.5 times the upper limit of normal (ULN)

Egyéb

• Patients with impaired renal function
• Patient is pregnant or breast feeding

• Have a primary diagnosis, or a high clinical suspicion, for cancer in the lung based on CT, biopsy, or other imaging.
• Are scheduled to undergo surgical thoracoscopy and resection of the lung.
• If of childbearing potential, the patient must have a negative serum pregnancy test at screening, on Day 1 prior to LS301-IT administration, as well as using a medically acceptable form of contraception (eg, hormonal birth control, double-barrier method) or abstinence.
• Ability to understand the requirements of the study