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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06915727
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
6 Months - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo tissue sample collection
  • Near Infrared Imaging — PROCEDURE
    Undergo NIR fluorescent imaging
  • Pafolacianine Sodium — DRUG
    Given IV
  • Surgical Procedure — PROCEDURE
    Undergo SOC surgery

Study Details

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.

Key Dates

Start date
Apr 15, 2025
Status verified
Mar 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Diagnostic (pafolacianine + NIR)
    Patients receive pafolacianine IV over 60 to 90 minutes and undergo NIR fluorescent imaging during standard of care (SOC) surgery on study. Patients also undergo collection of tissue during SOC surgery on study.

Primary Outcome Measure

Accuracy of Cytalux™ (pafolacianine) injection used with NIR fluorescent imaging for detecting lesions [ Time Frame: Up to 30 days after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Gina Lewis
[email protected]
507-284-0850
Clinical Trials Referral Office
[email protected]
855-776-0015
Stephanie F. Polites, MD, MPH (PRINCIPAL_INVESTIGATOR)

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