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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 1 patients will receive dose of 0.02 mg/kg
Enrolled subjects arrive at the infusion center for their infusions up to 8-36hours before the scheduled surgery to receive their injection of Pemefolacianine for Injection. cohorts 2 patients will receive dose of 0.04 mg/kg
University of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGNumber of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety of Pemefolacianine for Injection, as assessed by the incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and clinically significant changes in laboratory values, vital signs, physical examinations, and electrocardiograms (ECGs) from baseline through the end of the study.
Time frame: Day 1 through Day 30
Signal-to-Background Ratio in Intraoperative Tissue Images
Surgeon intraoperative semi-quantitative fluorescence assessments will be collected. Video images will be analyzed for fluorescence signal (eg, mean fluorescence intensity) and ratios (eg, signal-to-background, tumor/non-tumor) will be determined in various images and recorded. Descriptive statistics will be obtained and compared with histopathology and the surgeon's assessment of fluorescence in each tissue type.
Time frame: Day 2 surgery
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