Pafolacianine for Localization of Pediatric Extracranial Solid Tumors
Mayo Clinic
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.
Eligibility
- Age range
- 0–17 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Willingness of research participant or legal guardian/representative to give written informed consent * Age 6 months to 17 years * Have a diagnosis, or a high clinical suspicion, of a solid tumor in the neck, chest, abdomen, pelvis, or extremities with a plan for surgical resection including embryonal tumors, sarcomas, neurogenic tumors, carcinomas, mesenchymal tumors, germ cell tumors. Children may undergo surgical resection or biopsy of a solid tumor that is suspected to be malignant without a separate preoperative biopsy; therefore, the tumor type may not be definitiv…
Interventions
- ProcedureBiospecimen Collection
Undergo tissue sample collection
- ProcedureNear Infrared Imaging
Undergo NIR fluorescent imaging
- DrugPafolacianine Sodium
Given IV
- ProcedureSurgical Procedure
Undergo SOC surgery
Location
- Mayo Clinic in RochesterRochester, Minnesota