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
Single group
Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
DrugGiven IV
Cytoreduction (CC) Score
Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.
Sensitivity-True Positive Rate (TPR)
Sensitivity, or the True Positive Rate (TPR), is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be gastrointestinal cancer (and folate receptor (FR) positive) by central pathology relative to the total number of lesions confirmed to be gastrointestinal cancer (FR+) by central pathology, that is proportion of cancerous lesions that are fluorescent light positive.
Specificity-True Negative Rate (TNR)
Specificity, or the True Negative Rate (TNR), is defined as the proportion of fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology, relative to the total number of lesions that are negative for gastrointestinal cancer (FR-) by central pathology-that is, the proportion of non-cancer lesions that are fluorescent light negative.
Positive Predictive Value (PPV)
Positive Predictive Value (PPV) is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology relative to the total number of lesions removed that are fluorescent light positive-that is, the proportion of fluorescent light positive lesions that are cancerous.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Incidence rates of all treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) from the time of CYTALUX (PAFOLACIANINE) injection administration through the conclusion of study participation
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University of California, Irvine
Lead sponsor
On Target Laboratories
Collaborator
