This phase II trial studies whether CYTALUX™ and a special camera system can be used for the detection of tumor cells in patients with endometrial cancer who are planned for surgery. CYTALUX is a special diagnostic product (medicine) made from folate (a type of B vitamin) that’s linked to a glowing dye. When it’s given to a patient, it should attach to tumor cells because they usually have more folate “receptors” than normal cells. During surgery, doctors use a special camera with near-infrared light to see the glow from the dye, which makes the tumor cells light up. This approach may help surgeons spot tumors more clearly, even tiny or hidden spots that might be missed by the naked eye or by touch alone. This could help the doctor see the tumor cells better during the surgery, which may help her/him take out additional tumors or the tumor more completely.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07278986.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Janos Laszlo Tanyi
Phone: 215-662-3318
PRIMARY OBJECTIVE:
I. To assess the ability of pafolacianine sodium (CYTALUX™) (pafolacianine) injection used with near-infrared (NIR) fluorescent imaging for the detection of malignant tissue in subjects undergoing surgical resection for endometrial cancer.
SECONDARY OBJECTIVES:
I. To assess the safety of CYTALUX in subjects undergoing surgery for endometrial cancer.
II. To assess folate receptor (alpha and beta expression) in resected specimens.
EXPLORATORY OBJECTIVES:
I. To assess the feasibility of using genomic markers to predict utility of CYTALUX with NIR imaging.
II. To assess the feasibility of CYTALUX to identify sentinel lymph nodes.
OUTLINE:
Patients receive pafolacianine sodium intravenously (IV) over 60 minutes not less than 1 hour before and not more than 168 hours (7 days) before initiation of intraoperative NIR fluorescent imaging. Patients then undergo NIR fluorescent imaging during standard of care surgery for endometrial cancer in the absence of unacceptable toxicity. Patients also undergo tissue sample collection on study.
After completion of study intervention, patients are followed up at 4 weeks.
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorJanos Laszlo Tanyi
