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Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)

StatusRecruiting
PhasePhase 4
Started2025-09-05
View on ClinicalTrials.gov ↗
Record status
This record was last updated September 15, 2025 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-09-09
notable
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
PhasePhase 1→Phase 4
Start dateestimated 2025-08→confirmed 2025-09-05
Study sitesdetails revised at 1 of 1 site
2025-08-08
minor
Original filing
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).
Trial Details
NCT Number NCT07124351
Lead Sponsor Cedars-Sinai Medical Center
Collaborators: On Target Laboratories, LLC
Conditions Gastrointestinal Cancer, Gastric Cancer, Esophageal Cancer, Appendiceal Cancer
Enrollment 15 participants
Start Date 2025-09-05
Primary Completion 2026-08 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2025-09-15