CYTALUX Dose Extension Study

This is a prospective, multicenter, open-label, non-inferiority study designed to evaluate the clinical adequacy of intraoperative tumor fluorescence following administration of Cytalux™ (pafolacianine) injection at two different administration time windows in adult subjects undergoing surgery for known or suspected cancer in the lung or ovarian cancer.

The study will enroll adult patients with either malignant or non-malignant lung lesions with known or suspected lung cancer, or patients with a confirmed diagnosis of ovarian cancer, who are scheduled to undergo surgical resection. Cytalux™ (pafolacianine) injection is an FDA-approved optical imaging agent indicated as an adjunct for intraoperative identification of malignant and non-malignant pulmonary lesions in adults with known or suspected lung cancer, and for malignant lesions in adults with ovarian cancer.

Eligible participants will receive a single intravenous dose of Cytalux™ at the FDA-approved dose of 0.025 mg/kg. The dose level will remain consistent with the approved labeling. Participants will be assigned to one of two dosing windows.

During surgery, intraoperative molecular imaging will be performed to assess tumor fluorescence following administration of Cytalux™.

The primary objective of the study is to demonstrate non-inferiority of Cytalux™ administration within an extended dosing window of 120-168 hours prior to surgery compared with the currently approved administration windows (lung: 1-24 hours; ovarian: 1-9 hours).

Inclusion criteria

• Male and female patients 18 years of age and older
• Primary diagnosis, or a high clinical suspicion, of cancer in the lung warranting surgery based on CT/PET or other imaging obtained within 4 months of the screening visit, or have a primary diagnosis for ovarian cancer
• Scheduled to undergo surgical thoracoscopy for wedge resection or anatomic lung resection, or ovarian cancer debulking/cytoreduction
• Willingness of research participant or legal guardian/representative to give written informed consent

Exclusion criteria

• History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Subjects with a medical history of 'idiopathic anaphylaxis' will require evaluation.
• History of allergy to any of the components of Cytalux™ (pafolacianine)
• Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
• Known sensitivity to fluorescent light
• Impaired renal function defined as eGFR< 50 mL/min/1.73m2
• 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 >2x ULN for total bilirubin excluding those patients with Gilbert's syndrome
• Pregnant and/or lactating women
• Administration of folate, folic acid, or folate-containing supplements 48 hours before administration of Cytalux™ (pafolacianine)