NCT06915727

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

Pafolacianine for Localization of Pediatric Extracranial Solid Tumors

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 6 Months – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Childhood Malignant Solid Neoplasm
• Childhood Malignant Thoracic Neoplasm
• Malignant Abdominal Neoplasm
• Malignant Neck Neoplasm
• Malignant Pelvic Neoplasm
• Metastatic Childhood Malignant Solid Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo tissue sample collection
PROCEDURE	Near Infrared Imaging	Undergo NIR fluorescent imaging
DRUG	Pafolacianine Sodium	Given IV
PROCEDURE	Surgical Procedure	Undergo SOC surgery

Timeline

• Start date: 2025-04-15
• Primary completion: 2027-05-01
• Completion: 2027-05-01
• First posted: 2025-04-08
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study