Actively Recruiting
PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
Led by University of California, Irvine · Updated on 2026-02-27
10
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
Sponsors
U
University of California, Irvine
Lead Sponsor
O
On Target Laboratories
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
PhI Pilot Study Pafolacianine Inject for Intraoperative Imaging on Outcomes of GI Cancer Peritoneal Carcinomatosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Previous exposure to CYTALUX�24�a0(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�24�a0(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
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chao Family Comprehensive Cancer Center, University of California, Irvine
Orange, California, United States, 92868
Actively Recruiting
Research Team
C
Chao Family Comprehensive Cancer Center University of California, Irvine
CONTACT
U
University of California Irvine Medical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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