Cytalux (Pafolacianine) for Intraoperative Detection of Tumor Tissue in Patients Undergoing Surgical Resection for Digestive System, Genitourinary System and Female Reproductive System Cancers

Inclusion Criteria

• Male and Female patients 18 years of age and older
• Have a primary diagnosis, or a high clinical suspicion, of gastrointestinal or foregut, genitourinary, or gynecologic malignancies, warranting surgery
• Are scheduled to undergo surgical intervention for lesion resection or diagnostic laparoscopy for assessment of disease burden
• Willingness to stop the use of folate, folic acid, or folate-containing supplements within 48 hours before administration of Cytalux
• Willingness of research participant or legal guardian/representative to give written informed consent

Exclusion Criteria

• Any medical condition that in the opinion of the investigators could potentially jeopardize the safety of the subject
• 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) injection
• Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
• Positive urine pregnancy test prior to Cytalux™ (pafolacianine) administration (for women of child-bearing potential)