RecruitingPhase 3NCT06915727

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

Pafolacianine for Localization of Pediatric Extracranial Solid Tumors


Sponsor

Mayo Clinic

Enrollment

20 participants

Start Date

Apr 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 MonthsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an imaging dye called pafolacianine (Cytalux) in children and teenagers to help surgeons better identify solid tumor tissue during operations. The dye attaches to cancer cells and glows under special light, making tumors easier to see. **You may be eligible if...** - You are between 6 months and 17 years old - You have been diagnosed with — or are highly suspected to have — a solid tumor in the neck, chest, abdomen, pelvis, or limbs - You are scheduled for surgery to remove or biopsy the tumor - Your parent or guardian can provide written informed consent **You may NOT be eligible if...** - You have previously received pafolacianine (Cytalux) - You have had a severe allergic reaction (anaphylaxis) to products containing indocyanine green - You are allergic to any component of Cytalux - You received another investigational drug within the last 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo tissue sample collection

PROCEDURENear Infrared Imaging

Undergo NIR fluorescent imaging

DRUGPafolacianine Sodium

Given IV

PROCEDURESurgical Procedure

Undergo SOC surgery


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06915727


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