PhI Pilot Study Pafolacianine Injec for Intraoperative Imag Gastrointestinal Can Peritoneal Carcinomatosis
NCT Number: NCT06511037
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Gastrointestinal Cancer|Peritoneal Carcinomatosis
Interventions: DRUG: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging
Sponsor: University of California, Irvine
Collaborators: On Target Laboratories
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-07-31
Completion Date: 2026-09-30
Locations: Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California, 92868, United States

Summary:
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.

Primary Outcome Measures: 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., 1 year|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., 1 year|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., 1 year|Negative Predictive Value (NPV), Negative Predictive Value (NPV) 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 removed that are fluorescent light negative-that is, the proportion of fluorescent light negative lesions that are histologically negative for cancer., 1 year|Accuracy, Accuracy is defined as the proportion of fluorescent light positive lesions that are histologically confirmed to be FR+ and gastrointestinal cancer by central pathology and the fluorescent light negative lesions that are histologically negative for gastrointestinal cancer and FR- by central pathology relative to all lesions sampled., 1 year
Secondary Outcome Measures: 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, 30 days