Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

Inclusion criteria

• Patients 18 years of age and older of any sex.
• Have a primary diagnosis, or a high clinical suspicion, of gastroesophageal adenocarcinoma based on CT (computed tomography)/PET (positron emission tomography) or other imaging (Cohort 1) or diagnosis of appendiceal adenocarcinoma with a high clinical suspicion of peritoneal carcinomatosis (Cohort 2).
• Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal 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 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.
• Known sensitivity to fluorescent light.
• Women of childbearing potential who are pregnant or plan to become pregnant during the study.