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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00959 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| PEDSBRNCNS0008 | Other Identifier | Stanford Cancer Institute | |
| P30CA124435 | U.S. NIH Grant/Contract | View source | |
| PEDSBRNCNS0008 | Other Identifier | OnCore |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (ferumoxytol-enhanced MRI) | Experimental | All subjects in the experimental arm will have a single intravenous dose of ferumoxytol (5 mg Fe/kg), to be administered 24 hours before the subject undergoes ferumoxytol-enhanced magnetic resonance imaging (MRI). These subjects will subsequently undergo surgery, and tissue analysis of surgically resected samples (specifically the number of iron-containing and non-iron-containing macrophages) will be correlated with imaging features on ferumoxytol-enhanced MRI. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diagnostic (ferumoxytol-enhanced MRI) | Diagnostic Test | Undergo ferumoxytol-enhanced MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Iron concentration measurements | Obtain susceptibility measurements and relaxation times (R2, R2*, R2') in patients receiving ferumoxytol. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Macrophages on histopathology | Determine the number of macrophages in tissue samples at histopathology. | Days 2-4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Iv | Stanford University | Principal Investigator |
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| ID | Term |
|---|---|
| D003933 | Diagnosis |
| D000098543 | Dynamic Contrast Enhanced Magnetic Resonance Imaging |
| D013514 | Surgical Procedures, Operative |
| D052203 | Ferrosoferric Oxide |
| D046888 | Tissue Array Analysis |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| Surgery | Procedure | Undergo surgical resection |
|
| Ferumoxytol | Drug | Given IV |
|
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| Tissue Analysis | Other | Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion. |
|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
| D008903 | Minerals |
| D046228 | Microarray Analysis |
| D046208 | Microchip Analytical Procedures |
| D008919 | Investigative Techniques |