This is a pilot, single-arm, open label study to evaluate the ability of CYTALUX™ (pafolacianine) to help identify cancerous lesions in subjects with gastrointestinal cancers and peritoneal carcinomatosis during cytoreductive surgery.
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 by a negative urine pregnancy test on the day of scheduled study drug infusion, or day of surgery
Female patients of childbearing potential, or less than two (2) years postmenopausal, agree to use an acceptable form of contraception from time of signing informed consent until 30 days after study completion
Previous exposure to CYTALUX™ (PAFOLACIANINE)
Patients with known gastrointestinal cancer with carcinomatosis determined pre-operatively to be inoperable
Any medical condition that in the opinion of the investigators could potential jeopardize the safety of the patient
History of anaphylactic reaction
University of California, Irvine
Lead sponsor
On Target Laboratories
Collaborator