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

The Impact of Pafolacianine Injection for Intraoperative Imaging on Outcomes of Gastrointestinal Cancer Peritoneal Carcinomatosis - A Pilot Study

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Cancer; Peritoneal Carcinomatosis
• Intervention / Treatment: Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Chao Family Comprehensive Cancer Center University of California, Irvine; Phone Number: 1-877-827-8839; Email: ucstudy@uci.edu
• Study Contact Backup: Name: University of California Irvine Medical

Study Locations

• United States
  • California
    • Orange, California, United States, 92868
      • Recruiting
      • Chao Family Comprehensive Cancer Center, University of California, Irvine
      • Contact: Maheswari Senthil, MD; Phone Number: 877-827-8839; Email: ucstudy@uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Exclusion Criteria:

• 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
• History of allergy to any components of CYTALUX™ (PAFOLACIANINE), including folic acid
• 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) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
• Received an investigational agent in another trial within 30 days prior to surgery
• Known sensitivity to fluorescent light

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pafolacianine (CYTALUX); All subjects will receive one single intravenous infusion of 0.025 mg/kg of pafolacianine (CYTALUX) injection prior to anticipated intraoperative imaging planned for cytoreductive surgery.	Drug: Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging; Given IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Cytoreduction (CC) Score	Describe the completeness of cytroreduction (cc) score with Cytoreductive surgery (CRS) with Cytalux injection.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: On Target Laboratories
• Investigators: Principal Investigator: Maheswari Senthil, MD, Chao Family Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: July 15, 2024
• First Submitted That Met QC Criteria: July 15, 2024
• First Posted (Actual): July 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Peritoneal Diseases; Abdominal Neoplasms; Gastrointestinal Neoplasms; Peritoneal Neoplasms; Physical Phenomena; Electromagnetic Phenomena; Magnetic Phenomena; Electromagnetic Radiation; Radiation; Radiation, Ionizing; X-Rays; Pafolacianine
• Other Study ID Numbers: 4951; UCI 23-184 (Other Identifier: UCI CFCCC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes