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

NCT06915727 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-01

No results posted yet for this study

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

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

Sponsors & Collaborators

Principal Investigators

  • Stephanie F. Polites, MD, MPH · Mayo Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-15
Primary Completion
2027-05-01
Completion
2027-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06915727 on ClinicalTrials.gov