RECRUITING

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

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Conditions

Childhood Malignant Solid NeoplasmChildhood Malignant Thoracic NeoplasmMalignant Abdominal NeoplasmMalignant Neck NeoplasmMalignant Pelvic NeoplasmMetastatic Childhood Malignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pafolacianine for Localization of Pediatric Extracranial Solid Tumors

Quick Facts

Study Start:2025-04-15
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06915727

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Months to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Willingness of research participant or legal guardian/representative to give written informed consent
  2. * Age 6 months to 17 years
  3. * 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
  1. * Previous exposure to Cytalux™ (pafolacianine) injection
  2. * Any medical condition that in the judgement of the investigators could potentially jeopardize the safety of the participant
  3. * History of anaphylactic reactions to products containing indocyanine green for near infrared imaging. Participants with a medical history of 'idiopathic anaphylaxis' will require evaluation
  4. * History of allergy to any of the components of Cytalux™ (pafolacianine) injection
  5. * Presence of any psychological, familial, sociological condition or geographical challenges potentially hampering compliance with the study protocol or follow-up schedule
  6. * 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
  7. * Known sensitivity to fluorescent light
  8. * Pregnancy
  9. * Unable or unwilling to discontinue folic acid, folate supplements, and multi-vitamins containing folate 48 hours prior to drug administration
  10. * 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.
  11. * 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
  12. * Unable or unwilling to use adequate birth control/contraceptive measures or abstain from sexual activity for 30 days following the study intervention
  13. * Anticipated need to donate ova or sperm within 30 days following study intervention

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu
Gina Lewis
CONTACT
507-284-0850
DOSCRO2@mayo.edu

Principal Investigator

Stephanie F. Polites, MD, MPH
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2025-04-15
Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

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