Recruiting
Early Phase 1

Pafolacianine

Sponsor:

UCLA

Code:

NCT06511037

Conditions

Gastrointestinal Cancer

Peritoneal Carcinomatosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging

Study Details

Brief 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.

Conditions

Gastrointestinal Cancer

Peritoneal Carcinomatosis

Study ID

NCT06511037

Start date

Nov 13, 2024

Status verified date

Feb, 2026

Completion date

Nov 30, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Pafolacianine (CYTALUX) with intraoperative fluorescent near-infrared (NIR) imaging

Given IV

Primary outcome measure

  • Cytoreduction (CC) Score [ Time Frame: 1 year ]
  • Sensitivity-True Positive Rate (TPR) [ Time Frame: 1 year ]
  • Specificity-True Negative Rate (TNR) [ Time Frame: 1 year ]
  • Positive Predictive Value (PPV) [ Time Frame: 1 year ]
  • Negative Predictive Value (NPV) [ Time Frame: 1 year ]
  • Accuracy [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839ucstudy@uci.edu

Locations

Chao Family Comprehensive Cancer Center, University of California, Irvine

Recruiting

Orange, California, United States, 92868

Contacts

Maheswari Senthil, MD

877-827-8839ucstudy@uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-02-27.