A Phase IB, Single Dose, Open-Label, Dose-escalation Study to Investigate the Safety and Imaging Characteristics of Pemefolacianine for Intraoperative Molecular Imaging of Lung Cancer
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of Pemefolacianine for Injection, a novel fluorescence imaging agent developed by Nanjing Nuoyuan Medical Devices Co., Ltd (Nuoyuan Medical), administered by slow intravenous (IV) in patients undergoing surgical thoracoscopy and/or RATS (Robot-Assisted Thoracoscopic Surgery) resection of lung cancer. Safety is the primary objective of this study, followed by evaluation of the fluorescence signal as it relates to dose level and dosing time interval which will not be used for decision-making in the surgical resection in this study.
• Male or Female subjects greater than 18 years of age inclusive, at the time of signing the informed consent.
• 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 or open surgery (thoracotomy) 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 Pemefolacianine for Injection administration, as well as using a medically acceptable form of contraception
• Ability to understand the requirements of the study, provide written informed consent and authorization of use and disclosure of protected health information, and agree to abide by the study restrictions and to return for the required assessments