Study on Using Pafolacianine Imaging Agent to Identify Tumors in Children and Teens with Solid Tumors

Inclusion Criteria

• Children and teenagers aged 6 months to 17 years.
• Must have a diagnosis or strong suspicion of a solid tumor in areas like the neck, chest, abdomen, pelvis, or limbs, and be planning to have surgery to remove it.
• Tumor types can include embryonal tumors, sarcomas, neurogenic tumors, carcinomas, mesenchymal tumors, and germ cell tumors.
• Willingness of the participant or their legal guardian to provide written consent to participate in the study.

Exclusion Criteria

• Have previously received a pafolacianine injection.
• Have any medical condition that might make participation unsafe.
• Have had severe allergic reactions to similar imaging products.
• Have allergies to any ingredients in the pafolacianine injection.
• Have conditions that might make it difficult to follow the study schedule or procedures.
• Have participated in another drug or vaccine trial within 30 days before this study, unless the drug or vaccine is already FDA-approved.
• Have a known sensitivity to fluorescent light.
• Are pregnant.
• Cannot or will not stop taking folic acid, folate supplements, or multivitamins with folate 48 hours before receiving the study drug.
• Have severe kidney problems or are on dialysis.
• Are being evaluated for liver failure or are on a liver transplant list, with certain liver function test results exceeding specified limits.
• Cannot or will not use effective birth control or abstain from sexual activity for 30 days after the study.
• Plan to donate eggs or sperm within 30 days after the study.