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

Recruiting Phase 3 Interventional Study
Childhood Malignant Solid Neoplasm Childhood Malignant Thoracic Neoplasm Malignant Abdominal Neoplasm Malignant Neck Neoplasm Malignant Pelvic Neoplasm Metastatic Childhood Malignant Solid Neoplasm
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
6 Months – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
20 (estimated)
Sponsor
Mayo Clinic · Other
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About 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…
Trial Locations
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Eligibility 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 rese…
Contacts

Clinical Trials Referral Office

855-776-0015

mayocliniccancerstudies@mayo.edu

CONTACT

Gina Lewis

507-284-0850

DOSCRO2@mayo.edu

CONTACT