Actively Recruiting
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Led by Cedars-Sinai Medical Center · Updated on 2025-09-15
15
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
C
Cedars-Sinai Medical Center
Lead Sponsor
O
On Target Laboratories, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label study in adults to determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal).
CONDITIONS
Official Title
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age and older of any sex.
- Have a primary diagnosis or high clinical suspicion of gastroesophageal adenocarcinoma based on CT/PET or other imaging (Cohort 1) or diagnosis of appendiceal adenocarcinoma with high suspicion of peritoneal carcinomatosis (Cohort 2).
- Have an indication for surgical intervention for gastroesophageal tumor resection or diagnostic laparoscopy for assessment of peritoneal disease.
- Willingness to stop folate, folic acid, or folate-containing supplements within 48 hours before CYTALUX administration.
- Willingness to give written informed consent.
You will not qualify if you...
- Any medical condition that could jeopardize participant safety.
- History of anaphylactic reactions to indocyanine green or idiopathic anaphylaxis without evaluation.
- Allergy to any components of CYTALUX (pafolacianine) injection.
- Psychological, familial, sociological, or geographical challenges that could affect study compliance or follow-up.
- Known sensitivity to fluorescent light.
- Women of childbearing potential who are pregnant or plan to become pregnant during the study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
A
Amy Hoang
CONTACT
L
Laura Sarmiento
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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