Using a special imaging agent to find tumors in children with solid cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the effectiveness of pafolacianine, a fluorescent imaging agent, in identifying cancerous lesions in pediatric patients with primary or metastatic solid tumors. The agent targets folate receptors that are often overexpressed in various cancers and is used in conjunction with near infrared (NIR) imaging during surgical procedures. The goal is to improve the visualization and localization of tumor cells, potentially enhancing surgical outcomes for children with solid tumors.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
* Received an investigational agent in another investigational drug or vaccine trial within 30 days prior to the administration of the study drug. 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
* Known sensitivity to fluorescent light
* Pregnancy
* Unable or unwilling to discontinue folic acid, folate supplements, and multi-vitamins containing folate 48 hours prior to drug administration
* 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. Creatinine will be measured by enzymatic assay with calibration traceable to the international standard reference materials and minimal bias compared to isotope-dilution mass spectrometry (IDMS) reference methodology.
* 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
* Unable or unwilling to use adequate birth control/contraceptive measures or abstain from sexual activity for 30 days following the study intervention
* Anticipated need to donate ova or sperm within 30 days following study intervention

Where it's running

• Mayo Clinic in Rochester
  Rochester, Minnesota, United States Recruiting

Study contacts

• Principal investigator: Stephanie F. Polites, MD, MPH — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.