Pafolacianine for Identifying Lesions in Childhood Cancer

Overseen By Gina Lewis

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Mayo Clinic

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stephanie F. Polites, MD, MPH

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for children and adolescents with primary or metastatic solid tumors. Participants must have a type of cancer that could potentially overexpress folate receptors, making them suitable for the imaging agent being tested.

Inclusion Criteria

Willingness of research participant or legal guardian/representative to give written informed consent

I am between 6 months and 17 years old.

I am suspected to have or diagnosed with a solid tumor and surgery is planned.

Exclusion Criteria

My kidneys are not working properly.

I am being evaluated for liver failure or am on the liver transplant list.

I cannot or will not use birth control.

Treatment Details

Interventions

• Pafolacianine (Cancer Imaging Agent)

Trial Overview The study tests pafolacianine, an imaging agent used during surgery to light up cancer cells in kids. It's paired with near-infrared (NIR) imaging to help surgeons see and remove tumors more effectively than with standard methods.

Participant Groups

Group I: Diagnostic (pafolacianine + NIR) Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+