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Imaging Agent Pafolacianine for Pediatric Solid Tumors

This study is looking at how well a special imaging agent called pafolacianine (Cytalux™) helps doctors find cancerous lesions in children and teenagers with solid tumors. These tumors can be new (primary) or have spread (metastatic). Pafolacianine is given through a vein and works with near infrared (NIR) imaging, which uses a special camera during surgery to light up tumor cells. The goal is to see if pafolacianine and NIR imaging are better at finding these lesions. You may be able to join if you are between 6 months and 17 years old and have a solid tumor in certain areas of the body that needs surgery. The study plans to include 20 participants.

Study design
This is a Phase III interventional study planning to enroll 20 participants. It is not specified if it is randomized, blinded, or open-label.
What's involved
You would undergo tissue sample collection, receive pafolacianine intravenously, have near infrared fluorescent imaging, and undergo standard-of-care surgery.
Compensation
Not stated in the trial record.
Follow-up
Your accuracy for detecting lesions will be measured up to 30 days after surgery.

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NCT06915727

An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors

Recruiting
PHASE3Ages 6–17InterventionalDiagnostic
Mayo Clinic
~20 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Biospecimen CollectionNear Infrared ImagingPafolacianine SodiumSurgical Procedure

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of Cytalux™ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesions
Measured over Up to 30 days after surgery

Conditions

Childhood Malignant Solid Neoplasm
Childhood Malignant Thoracic Neoplasm
Malignant Abdominal Neoplasm
Malignant Neck Neoplasm
Malignant Pelvic Neoplasm
Metastatic Childhood Malignant Solid Neoplasm

Explore related trials

CarcinomaEmbryonal NeoplasmGerm Cell TumorMesenchymal Cell NeoplasmNeurogenic TumorSarcomaSolid Neoplasm

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Stephanie F. Polites, MD, MPH · PRINCIPAL_INVESTIGATOR · Mayo Clinic

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
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

What this trial measures

  • Accuracy of Cytalux™ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesionsUp to 30 days after surgery

    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.