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.
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 definitively known preoperatively
Previous exposure to Cytalux™ (pafolacianine) injection
Any medical condition that in the judgement of the investigators could potentially jeopardize the safety of the participant
History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Participants with a medical history of 'idiopathic anaphylaxis' will require evaluation
History of allergy to any of the components of Cytalux™ (pafolacianine) injection
Single group
Biospecimen Collection
Procedure/SurgeryUndergo tissue sample collection
Near Infrared Imaging
Procedure/SurgeryUndergo NIR fluorescent imaging
Pafolacianine Sodium
DrugGiven IV
Surgical Procedure
Procedure/SurgeryUndergo SOC surgery
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 between Cytalux™ administration and NIR imaging detection intraoperatively
Descriptive statistics will be performed and descriptive summaries such as mean (standard deviation) or median (minimum, maximum) for continuous variables and frequencies and percentages for categorical variables will be reported.
Reasons for not excising NIR avid lesions
Descriptive statistics will be performed and descriptive summaries such as mean (standard deviation) or median (minimum, maximum) for continuous variables and frequencies and percentages for categorical variables will be reported. All tests will be two sided and p-values less than 0.05 will be considered statistically significant.
Incidence of Adverse Events surgery
Cytalux™ (pafolacianine) will be assessed for safety in children and adolescent patients undergoing by the number and severity of adverse events (AEs), defined as events (serious or non-serious) of scientific and medical concern specific to the investigational product and/or the combination of products being used in a study. AEs will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
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