Intraoperative Imaging of Gastrointestinal Malignancies Using Pafolacianine (CYTALUX™)
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).
Arms & 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.
Outcome measures
Primary
Feasibility of CYTALUX™ (pafolacianine) with near-infrared (NIR) fluorescent imaging
Determine feasibility of using CYTALUX™ (pafolacianine) injection with near-infrared (NIR) fluorescent imaging for detecting any type adenocarcinoma (gastric, esophageal and appendiceal) in at least 70% of the patients.
Time frame: 12 months
Secondary
Number of Lesions
Time frame: 12 months
Eligibility criteria
Study locations (1)
Cedars-Sinai Medical Center
Los Angeles, California, 90048