In Vivo Characterization of Macrophages in Pediatric Patients With Malignant Brain Tumors Using Ferumoxytol-enhanced MRI
| Status: | Recruiting |
|---|---|
| Conditions: | Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 2 - Any |
| Updated: | 9/9/2018 |
| Start Date: | July 1, 2017 |
| End Date: | July 1, 2019 |
| Contact: | Paymon Rezaii |
| Email: | prezaii@stanford.edu |
| Phone: | 650-743-8336 |
MR Imaging of Inflammatory Responses in the Central Nervous System With Ferumoxytol-Enhanced MRI (Pediatric Brain Tumor Protocol)
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.
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.
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.
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.
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
We found this trial at
1
site
Palo Alto, California 94304
Principal Investigator: Michael Iv
Phone: 650-743-8336
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