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PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

NCT06511037•University of California, Irvine

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

Key Dates

Start Date

November 13, 2024

Primary Completion Date

November 30, 2026

Completion Date

November 30, 2027

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Gastrointestinal CancerPeritoneal Carcinomatosis

Interventions

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

DRUG

Contacts

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

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

University of California Irvine Medical

CONTACT

Resilience and Equity in Aging, Cancer, and Health (REACH)

NCT04674267

Gastric CancerColon Cancer+4 more

View study

RECRUITINGPHASE1/PHASE2

Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

NCT06596694

Gastrointestinal Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Resilience and Equity in Aging, Cancer, and Health (REACH)

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