OncoMatch/Clinical Trials/NCT06915727
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Is NCT06915727 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Pafolacianine Sodium for childhood malignant solid neoplasm.
Treatment: Pafolacianine Sodium — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
Metastatic Childhood Malignant Solid Neoplasm
Prior therapy
Cannot have received: pafolacianine (Cytalux)
Previous exposure to Cytalux™ (pafolacianine) injection
Cannot have received: investigational agent
Exception: Investigational trials involving administration of drugs or vaccines which are already Food and Drug Administration (FDA)-approved, such as Children's Oncology Group cooperative trials, are okay
Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of the study drug
Lab requirements
Kidney function
Renal failure on dialysis or estimated glomerular filtration rate (eGFR) < 30 mL/min/1.72m^2 as measured by the U25 eGFR equation for patients ≥1 year(s) of age. For patients < 1 year of age, creatinine > 2x the upper limit of normal will serve as an exclusion criteria.
Liver function
Undergoing workup for liver failure or listed for liver transplant. Patients with Gilbert's syndrome will be excluded if impaired liver function defined as values > 3x the upper limit of normal (ULN) for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin
Renal failure on dialysis or eGFR < 30 mL/min/1.72m^2... For patients < 1 year of age, creatinine > 2x ULN... Undergoing workup for liver failure or listed for liver transplant. Patients with Gilbert's syndrome will be excluded if impaired liver function defined as values > 3x ULN for ALT, AST, ALP, or total bilirubin
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify