Using Pafolacianine and Near Infrared Imaging to Locate Solid Tumors in Children and Teens Ages 6 Months to 17 Years

What this Trial Is About

Researchers are evaluating how well pafolacianine works to identify cancerous lesions in children and adolescents with primary or metastatic solid tumors. This phase III trial focuses on using pafolacianine, a fluorescent imaging agent that targets folate receptors often found in many cancers. The agent is combined with near infrared NIR imaging during surgery to help locate tumor cells more effectively in pediatric patients with solid tumors. Participants receive an intravenous infusion of pafolacianine over 60 to 90 minutes before undergoing NIR fluorescent imaging during their planned standard of care surgery. During surgery, tissue samples are collected for analysis. This study involves only one experimental group using pafolacianine combined with NIR imaging to assist tumor detection during surgery. Throughout the trial, researchers monitor the accuracy of pafolacianine with NIR imaging in detecting lesions up to 30 days after surgery. They also measure the time between pafolacianine administration and imaging detection, reasons for not removing certain lesions, and any adverse events related to surgery. Participants are closely followed to assess safety and effectiveness of this imaging method as part of their surgical care.

An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors