PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis

Inclusion Criteria:

• Adult patients 18 years of age and older

• Have a primary diagnosis of primary gastrointestinal cancer (of adenocarcinoma),planned for cytoreductive surgery

• Female patients must have a negative serum pregnancy test at screening, followed bya negative urine pregnancy test on the day of scheduled study drug infusion, or dayof surgery

• Female patients of childbearing potential, or less than two (2) yearspostmenopausal, agree to use an acceptable form of contraception from time ofsigning informed consent until 30 days after study completion

• Ability to understand the requirements of the study, provide written informedconsent for participation in the study and authorization of use and disclosure ofprotected health information, and agree to abide by study restrictions

Exclusion Criteria:

• Previous exposure to CYTALUX™ (PAFOLACIANINE)

• Patients with known gastrointestinal cancer with carcinomatosis determinedpre-operatively to be inoperable

• Any medical condition that in the opinion of the investigators could potentialjeopardize the safety of the patient

• History of anaphylactic reaction

• History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folicacid

• Pregnancy, or positive pregnancy test

• Clinically significant abnormalities on ECG

• Impaired renal function defined as eGFR <50 mL/min/1.73m2

• Impaired liver function defined as values >3x the upper limit of normal (ULN) foralanine aminotransferase (ALT), aspartate aminotransferase (AST), alkalinephosphatase (ALP), or total bilirubin

• Received an investigational agent in another trial within 30 days prior to surgery

• Known sensitivity to fluorescent light