Actively Recruiting
Pafolacianine for Localization of Pediatric Extracranial Solid Tumors
Led by Mayo Clinic · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well pafolacianine works to identify cancerous lesions in children and adolescents with primary or metastatic solid tumors. This phase III trial focuses on using pafolacianine, a fluorescent imaging agent that targets folate receptors often found in many cancers. The agent is combined with near infrared (NIR) imaging during surgery to help locate tumor cells more effectively in pediatric patients with solid tumors. Participants receive an intravenous infusion of pafolacianine over 60 to 90 minutes before undergoing NIR fluorescent imaging during their planned standard of care surgery. During surgery, tissue samples are collected for analysis. This study involves only one experimental group using pafolacianine combined with NIR imaging to assist tumor detection during surgery. Throughout the trial, researchers monitor the accuracy of pafolacianine with NIR imaging in detecting lesions up to 30 days after surgery. They also measure the time between pafolacianine administration and imaging detection, reasons for not removing certain lesions, and any adverse events related to surgery. Participants are closely followed to assess safety and effectiveness of this imaging method as part of their surgical care.
CONDITIONS
Brief Title
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness of participant or guardian to give written informed consent
- Age between 6 months and 17 years
- Diagnosis or strong suspicion of a solid tumor in the neck, chest, abdomen, pelvis, or extremities
- Planned surgical resection or biopsy of the solid tumor
- Tumor types may include embryonal tumors, sarcomas, neurogenic tumors, carcinomas, mesenchymal tumors, or germ cell tumors
You will not qualify if you...
- Previous exposure to Cytalux (pafolacianine) injection
- Any medical condition that may jeopardize participant safety
- History of anaphylactic reactions to indocyanine green or components of Cytalux
- Psychological, familial, sociological, or geographical issues interfering with study compliance
- Participation in another investigational drug or vaccine trial within 30 days prior
- Known sensitivity to fluorescent light
- Pregnancy
- Unable or unwilling to stop folic acid, folate supplements, or multivitamins containing folate 48 hours before drug administration
- Renal failure requiring dialysis or low kidney function (eGFR < 30 mL/min/1.72m²)
- Workup for liver failure or listed for liver transplant; impaired liver function beyond specified limits
- Unable or unwilling to use birth control or abstain from sexual activity for 30 days after intervention
- Anticipated need to donate eggs or sperm within 30 days after intervention
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 0 to 1
Participants receive an intravenous injection of pafolacianine and undergo near infrared (NIR) fluorescent imaging during their standard of care surgery to identify lesions.
1 surgical procedure visit (in-person)
Duration - Up to 30 days after surgery
Participants are monitored for up to 30 days after surgery to assess the accuracy of lesion detection and observe any adverse events.
Approximately 1 to 2 follow-up visits (in-person or remote)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
G
Gina Lewis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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