NCT07124351

Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Gastrointestinal Cancer
• Gastric Cancer
• Esophageal Cancer
• Appendiceal Cancer

Interventions

Type	Name	Description
DRUG	CYTALUX™ (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.

Timeline

• Start date: 2025-09-05
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2025-08-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study