In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
NCT03179449 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL
Last updated 2023-04-14
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.
Conditions
- Childhood Brain Neoplasm
Interventions
- DIAGNOSTIC_TEST
-
Diagnostic (ferumoxytol-enhanced MRI)
Undergo ferumoxytol-enhanced MRI
- PROCEDURE
-
Surgery
Undergo surgical resection
- DRUG
-
Ferumoxytol
Given IV
- OTHER
-
Tissue Analysis
Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Michael Iv
lead OTHER
Principal Investigators
-
Michael Iv · Stanford University
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-07-01
- Primary Completion
- 2025-06-01
- Completion
- 2025-06-01
- FDA Drug
- Yes
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