A Phase 2 Open-label Study to Evaluate the Safety and Efficacy of VGT-309 a Tumor-Targeted Activatable Fluorescent Imaging Agent to Identify Cancer in Subjects Undergoing Lung Cancer Surgery

To evaluate the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of VGT-309 to detect cancer utilizing near-infrared (NIR) fluorescence and histopathology results. 1. Sensitivity: defined as the probability that the tissue fluoresces when it is cancer, as confirmed by histology (TP/(TP+FN)) 2. Specificity: defined as the probability that the tissue does not fluoresce when it is not cancerous as confirmed by histology (TN/(TN+FP)) 3. Positive predictive value (PPV): defined as the probability that a tissue sample contains cancer on histologic exam if it fluoresces (TP/(TP+FP)) 4. Negative predictive value (NPV): defined as the probability that the tissue sample does not contain cancer on histologic exam if it does not fluoresce (TN/(TN+FN)) For each of the defined Clinically Significant Events: A. Number of pulmonary nodules visualized using VGT-309 NIR imaging and confirmed histologically that would not otherwise be found by conventional modalities available to the surgeon. B. Number of subjects where at least one synchronous lesion is identified with VGT-309 NIR imaging, but not with conventional modalities available to the surgeon (white light, palpation, and/or pre-operative imaging), and it proves to be histologically cancer. C. Number of subjects where at least one positive margin is identified by VGT-309 NIR imaging and pathology demonstrates cancer cells within 5 mm of the margin.

You may be eligible for this study if you meet the following criteria:

• Conditions: Medical Research
• Age: 99 years or below
• Gender: All