RecruitingPhase 4NCT07124351

Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

Sponsor

Cedars-Sinai Medical Center

Enrollment

15 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

Esophageal Cancer Gastric Cancer Gastrointestinal Cancer Appendiceal Cancer

Summary

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special dye called pafolacianine (CYTALUX) that lights up cancer cells during surgery, helping surgeons better identify and remove gastrointestinal cancers (stomach, esophageal, or appendix cancers) more completely. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with, or are highly suspected to have, stomach/esophageal adenocarcinoma or appendix adenocarcinoma - You are scheduled to undergo surgery for your cancer **You may NOT be eligible if...** - You have known allergies to folate-related compounds - You are pregnant or breastfeeding - Your cancer type or stage does not fit the study criteria - You have certain medical conditions that could interfere with the dye or surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCYTALUX™ (pafolacianine)

All subjects participating in the study are expected to receive CYTALUX™ (pafolacianine) injection and standard care surgery; 1 to 24 hours after CYTALUX™ (pafolacianine) injection infusion is completed, all tumors planned to be removed as part of standard care will undergo assessment with NIR light imaging both intraoperatively and on the back table following surgery.