Actively Recruiting
Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX17)
Led by Cedars-Sinai Medical Center · Updated on 2025-09-15
15
Participants Needed
1
Research Sites
4 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
Researchers are evaluating the use of CYTALUX17 (pafolacianine) injection combined with near-infrared (NIR) fluorescent imaging to detect adenocarcinomas of the gastrointestinal tract, including gastric, esophageal, and appendiceal cancers. This open-label Phase 4 study aims to determine the feasibility of using this imaging method during surgery to better identify tumors in adults diagnosed with or suspected of having these cancers. Participants will receive an intravenous dose of CYTALUX17 at 0.025 mg/kg infused over one hour, administered between one and 24 hours before their planned surgery. During surgery, the tumors scheduled for removal will be assessed using NIR light imaging both intraoperatively and on the back table after surgery. All participants also receive standard surgical care as part of the study. Throughout the study, researchers will monitor the feasibility of using CYTALUX17 with NIR imaging over 12 months and record the number of lesions detected. Participants will undergo surgery with imaging assessments integrated, and follow-up will involve evaluating imaging results and safety. The total participation duration aligns with standard surgical care and a 12-month observation period for outcomes.
CONDITIONS
Brief 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
- Primary diagnosis or high suspicion of gastroesophageal adenocarcinoma or appendiceal adenocarcinoma with suspected peritoneal carcinomatosis
- Indication for surgical intervention for tumor resection or diagnostic laparoscopy
- Willingness to stop folate, folic acid, or folate-containing supplements within 48 hours before study drug administration
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Any medical condition that could jeopardize safety as judged by investigators
- History of anaphylactic reactions to indocyanine green or idiopathic anaphylaxis without evaluation
- Allergy to any components of CYTALUX17 (pafolacianine) injection
- Psychological, familial, sociological, or geographical challenges interfering with study compliance
- Known sensitivity to fluorescent light
- Pregnant women or women planning to become pregnant during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 hours before and during surgery
Participants receive an intravenous infusion of CYTALUX™ (pafolacianine) 1 to 24 hours before surgery. During surgery, tumors are assessed using near-infrared fluorescent imaging.
1 infusion visit and surgery visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and outcomes related to the imaging and surgery.
Follow-up visits as scheduled post-surgery
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
A
Amy Hoang
L
Laura Sarmiento
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here