Actively Recruiting
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Led by Mayo Clinic · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
An Imaging Agent (Pafolacianine) for Identifying Lesions in Pediatric Patients With Primary or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness of participant or guardian to provide written informed consent
- Age between 6 months and 17 years
- Diagnosis or strong suspicion of a solid tumor in the neck, chest, abdomen, pelvis, or extremities with plan for surgical removal or biopsy
- Tumor types may include embryonal tumors, sarcomas, neurogenic tumors, carcinomas, mesenchymal tumors, or germ cell tumors
- Surgical resection or biopsy planned even if tumor type is not definitively known before surgery
You will not qualify if you...
- Previous exposure to Cytalux (pafolacianine) injection
- Any medical condition that could risk participant safety
- History of anaphylactic reaction to indocyanine green or similar products
- Allergy to any component of Cytalux (pafolacianine) injection
- Psychological, familial, social, or geographic issues interfering with study compliance or follow-up
- Use of another investigational drug or vaccine within 30 days prior to study drug administration (except FDA-approved drugs used in certain cooperative trials)
- Known sensitivity to fluorescent light
- Pregnancy
- Inability or unwillingness to stop folic acid, folate supplements, or multivitamins containing folate 48 hours before drug administration
- Renal failure on dialysis or low kidney function (eGFR < 30 mL/min/1.72m2 for patients ≥1 year old; creatinine >2x upper limit of normal for those under 1 year)
- Under evaluation for liver failure or listed for liver transplant; impaired liver function shown by high liver enzyme or bilirubin levels
- Inability or unwillingness to use adequate birth control or abstain from sexual activity for 30 days after study intervention
- Anticipated need to donate eggs or sperm within 30 days after study intervention
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
CONTACT
G
Gina Lewis
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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