Safety and Feasibility of Intraoperative Visualization With Cytalux in Children

Exclusion Criteria10

• 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 also be excluded.
• 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
• 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 except in subjects with Gilbert's syndrome.
• Patient unable or unwilling to discontinue folate, folic acid, or folate-containing supplements 48 hours before study drug administration
• History of drug-related serious adverse event with prior Cytalux administration will be an exclusion for re-enrollment for contralateral surgery (see section 5.7).
• Participants will be excluded if their 12th or 18th birthday would occur during study participation
• Male sex at birth and commitment to acceptable form of contraception from time of consent through 30 days after study intervention with confirmed abstinence as an acceptable form of contraception as an inclusion criterion.