Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT03179449 |
Other study ID # |
IRB-39245 |
Secondary ID |
NCI-2017-00959PE |
Status |
Withdrawn |
Phase |
Early Phase 1
|
First received |
|
Last updated |
|
Start date |
July 1, 2017 |
Est. completion date |
June 1, 2025 |
Study information
Verified date |
April 2023 |
Source |
Stanford University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
PRIMARY OBJECTIVE:
I. To establish the magnetic resonance (MR) imaging signal characteristics of macrophages in
pediatric patients (>= 2 years old) with newly diagnosed malignant brain tumors using
ferumoxytol, an ultrasmall superparamagnetic iron oxide (USPIO) particle.
SECONDARY OBJECTIVES:
I. To correlate the MRI signal of ferumoxytol uptake in macrophages with the number of
macrophages in surgical tumor specimen at histopathology.
OUTLINE:
Patients receive a single intravenous infusion of ferumoxytol over 15 minutes. After 24
hours, patients undergo ferumoxytol-enhanced magnetic resonance imaging (MRI). Patients will
then undergo MRI-localized tissue sampling and tumor resection.