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

This phase III trial studies how well pafolacianine works for identifying cancerous lesions in children and adolescent patients with primary solid tumors or solid tumors that have spread from where they first started (primary site) to other places in the body (metastatic). Pafolacianine is a fluorescent imaging agent that targets folate receptors which are overexpressed in many cancers and is used with near infrared (NIR) imaging during surgery to identify tumor cells. NIR uses a special camera that uses wavelengths in the infrared range to visualize and locate the tumor cells that are lit up by the pafolacianine. Giving pafolacianine for NIR imaging may work better than other imaging agents in identifying cancerous lesions in pediatric patients with solid tumors.

NCT Number	NCT06915727
Lead Sponsor	Mayo Clinic
Conditions	Childhood Malignant Solid Neoplasm, Childhood Malignant Thoracic Neoplasm, Malignant Abdominal Neoplasm, Malignant Neck Neoplasm, Malignant Pelvic Neoplasm, Metastatic Childhood Malignant Solid Neoplasm
Enrollment	20 participants
Start Date	2025-04-15
Primary Completion	2027-05-01 (estimated)
Study Completion	2027-05-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-01