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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00227 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 1562 | |||
| 2864 | |||
| SOL-09064-LX | |||
| 813 | |||
| 5405 | Other Identifier | OHSU Knight Cancer Institute | |
| R01CA137488 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial studies dynamic susceptibility-weighted contrast enhanced magnetic resonance imaging (DSC-MRI) after administration of ferumoxytol and dynamic contrast-enhanced MRI (DCE-MRI) after administration of a gadolinium-based contrast agent (GBCA) in viewing the vessels of the brain in younger patients with brain tumors. Ferumoxytol is an experimental form of very small iron particles that are taken by the blood stream to cells adjacent and inside the tumor. These iron particles may make it easier to see the areas of the brain that are affected by tumor. Ferumoxytol may work better than standard GBCA in viewing the vessels of the brain and brain tumor on MRI. Using ferumoxytol and GBCA in the same MRI session may provide more information about tumor blood supply and the extent of the tumor.
PRIMARY OBJECTIVES:
I. To describe the vascular properties of pediatric brain tumors using ferumoxytol for DSC-MRI and GBCA for DCE-MRI in pediatric brain tumor (proven or presumptive) patients in a single MRI session.
II. To describe evolving imaging characteristics of tumor vasculature using DSC-MRI with ferumoxytol and DCE-MRI with GBCA in pediatric brain tumor patients.
SECONDARY OBJECTIVES:
I. Compare and evaluate magnetic resonance angiogram (MRA) with ferumoxytol between different time points.
II. To describe number and size of tumors imaged. III. To assess histology and electron microscopy (EM) on tissue samples. IV. To demonstrate differences in patients with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).
OUTLINE:
Patients receive ferumoxytol and gadolinium intravenously (IV) and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.
After completion of study treatment, patients are followed up at approximately 4-6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (DSC-MRI with ferumoxytol, DCE-MRI with gadolinium) | Experimental | Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | Undergo DCE-MRI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol | Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA). | Up to 2 years |
| Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent | Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained. | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol) | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Up to 2 years |
| Number of Enhancing Lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Neuwelt | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) | Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging | Procedure | Undergo DSC-MRI |
|
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| Ferumoxytol Non-Stoichiometric Magnetite | Drug | Given IV |
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| Gadolinium | Drug | Given IV |
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Appropriate descriptive statistics will be estimated. Results will be posted at overall completion.
| Up to 2 years |
| Tumor Vascularity | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Up to 2 years |
| Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol) | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Up to 2 years |
| Volume of Enhancing Lesions | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Up to 2 years |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) | Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Vascular Properties of Pediatric Brain Tumors Using Dynamic Susceptibility-weighted Contrast Enhanced MRI (DSC-MRI) After Administration of Ferumoxytol | Signal intensity, relative cerebral blood volume (rCBV) was measured. Relative CBV measurements were calculated from regions of interest (ROI) that were placed in regions of highest perfusion seen on the rCBV color overlay parametric maps.The mean of 3 regions of contralateral white matter was used as the internal reference standard. The size of the ROIs was kept constant (radius 1.5 mm). Parametric color overlay maps were analyzed using ImageJ software (NIH, Bethesda, MD, USA). | 7 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome. | Posted | Mean | Standard Deviation | mL/g | Up to 2 years |
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| Primary | Vascular Properties of Pediatric Brain Tumors Using Dynamic Contrast-enhanced MRI (DCE-MRI) After Administration of a Gadolinium-based Contrast Agent | Volume transfer coefficient reflecting vascular permeability of pediatric brain tumors using Dynamic Contrast-enhanced MRI (DCE-MRI) was measured. Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained. | 7 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome. | Posted | Mean | Standard Deviation | min^-1 | up to 2 years |
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| Secondary | Histology (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol) | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Due to low enrollment and staffing issues, data was not collected for this outcome. | Posted | Up to 2 years |
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| Secondary | Number of Enhancing Lesions | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Due to low enrollment and staffing issues, data was not collected for this outcome. | Posted | Up to 2 years |
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| Secondary | Tumor Vascularity | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Due to low enrollment and staffing issues, data was not collected for this outcome. | Posted | Up to 2 years |
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| Secondary | Ultrastructure (Only in Patients for Whom a Biopsy or Surgery is Scheduled Outside of This Protocol) | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Due to low enrollment and staffing issues, data was not collected for this outcome. | Posted | Up to 2 years |
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| Secondary | Volume of Enhancing Lesions | Appropriate descriptive statistics will be estimated. Results will be posted at overall completion. | Due to low enrollment and staffing issues, data was not collected for this outcome. | Posted | Up to 2 years |
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Assessed up to 2 years
All grades of adverse events were collected using Common Terminology Criteria for Adverse Events_v3.0 (CTCAE) (http://ctep.cancer.gov/protocolDevelopment/electronic\_applications/ctc.htm)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium) | Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years. Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI Ferumoxytol Non-Stoichiometric Magnetite: Given IV Gadolinium: Given IV | 1 | 14 | 2 | 14 | 8 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Shunt malfunction and revision | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Death | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diplopia | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Nystagmus | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| seizure | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| headache | Nervous system disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| teleangiectasia | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Fever | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Viral infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Fatigue | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Body aches | General disorders | CTCAE (3.0) | Non-systematic Assessment |
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| Shunt infection | Infections and infestations | CTCAE (3.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Neuwelt, MD | OHSU KCI | 503-494-5626 | huddlesa@ohsu.edu |
| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| D005682 | Gadolinium |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
| D008903 | Minerals |
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D008670 | Metals |
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