Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer.

PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 19, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Esophageal CancerGastrointestinal CancersGynecologic Cancers
Interventions
DRUG

CYTALUX™ (pafolacianine) injection preoperatively

CYTALUX™ (pafolacianine) injection: folate analog ligand conjugated with an indole cyanine green-like dye as a solution in vials containing 1.6 mL at 2 mg/mL. Each subject will be administered a single intravenous dose of not less than 1 hours before and not more than 24 hours before initiation of intraoperative NIR fluorescent imaging.

Trial Locations (1)

75235

RECRUITING

Clemments University Hospital, Dallas

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

On Target Laboratories, LLC

INDUSTRY

lead

John Waters

OTHER

NCT07039526 - Single Dose Investigator Initiated Pilot Study to Investigate CYTALUX (Pafolacianine) for Intraoperative Detection of Malignant Tissue in Subjects Undergoing Surgical Resection for Cancer. | Biotech Hunter | Biotech Hunter