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.
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…
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