In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot early phase I trial studies how well ferumoxytol-enhanced magnetic resonance imaging (MRI) correlates with inflammatory (macrophage) responses in pediatric patients with malignant brain tumors. If there is good correlation, ferumoxytol-enhanced MRI can serve as a noninvasive imaging biomarker of inflammation.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Iv
• Collaborator: National Cancer Institute (NCI)
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• Any patient with suspected malignant brain tumor on diagnostic MR imaging who will undergo a resection

Exclusion Criteria:

• Informed consent cannot be obtained either from the patient or legal representative

• Severe coexisting or terminal systemic disease that may interfere with the conduct of the study

• Contraindication to MRI (metal implants)

• Hemosiderosis/hemochromatosis

• Iron overload from any cause (not just hemosiderosis or hemochromatosis), even if secondary to frequent blood transfusions, severe chronic hemolysis, excess dietary or parenteral iron, or any other etiology

• Known hypersensitivity to ferumoxytol or any of its components

• Pregnant patients