OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules

Exclusion Criteria

• •1. Previous exposure to OTL38
• •2. Known Folate Receptor-negative lung nodules
• •3. Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the patient
• •4. History of anaphylactic reactions or severe allergies
• •5. History of allergy to any of the components of OTL38, including folic acid
• •6. Pregnancy, or positive pregnancy test
• •7. Clinically significant abnormalities on electrocardiogram (ECG) at screening.
• •8. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
• •9. Impaired renal function defined as epidermal growth factor receptor (eGFR) \< 50 mL/min/1.73m2
• •10. Impaired liver function defined as values \> 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin.
• •11. Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to surgery
• •12. Known sensitivity to fluorescent light