Pafolacianine for Localization of Pediatric Extracranial Solid Tumors
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.
Arms & interventions
- ProcedureBiospecimen Collection
Undergo tissue sample collection
- ProcedureNear Infrared Imaging
Undergo NIR fluorescent imaging
- DrugPafolacianine Sodium
Given IV
- ProcedureSurgical Procedure
Undergo SOC surgery
Outcome measures
Primary
Accuracy of Cytalux™ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesions
Each excised specimen will be analyzed for histologic findings to determine accuracy of Cytalux™ (pafolacianine) injection used with near infrared (NIR) fluorescent imaging for detecting lesions. Accuracy will be assessed using sensitivity and specificity.
Time frame: Up to 30 days after surgery
Secondary
Time between Cytalux™ administration and NIR imaging detection intraoperatively
Time frame: Day 0 to 1
Reasons for not excising NIR avid lesions
Time frame: Day 0 to 1
Incidence of Adverse Events surgery
Time frame: From study enrollment up to 30 days after surgery
Eligibility criteria
Study locations (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905