Using a special imaging agent to find tumors in children with solid cancers
Pafolacianine for Localization of Pediatric Extracranial Solid Tumors
This study is testing a special imaging agent to see if it can help doctors find tumors more easily during surgery in children with solid cancers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Months to 17 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06915727 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 6 months to 17 years with a diagnosis or high suspicion of solid tumors in various body regions who are scheduled for surgical resection.
Not a fit: Patients with a history of severe allergic reactions to imaging agents or those with medical conditions that could jeopardize their safety may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate identification of tumors, improving surgical outcomes and overall treatment for pediatric cancer patients.
How similar studies have performed: Other studies have shown promise with similar imaging agents, but the specific use of pafolacianine in pediatric patients represents a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Rochester, Minnesota
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.