| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00226 | Other Identifier | National Cancer Institute | |
| ONC-03095-LX | Other Identifier | OHSU Knight Cancer Institute | |
| IRB00000813 | 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 magnetic resonance imaging (MRI) using a contrast imaging agent ferumoxytol (ferumoxytol non-stoichiometric magnetite) in improving viewing tumors in patients with high-grade brain tumors or cancer that has spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose brain tumors and find out how far the disease has spread. The contrast imaging agent ferumoxytol non-stoichiometric magnetite consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It may help visualize the blood flow going through the tumor better than the standard substance gadolinium-based contrast agent.
PRIMARY OBJECTIVES:
I. Investigate the utility of ferumoxytol and gadolinium-based contrast agent (GBCA) for improved imaging biomarkers of malignant brain tumors in a single imaging session by comparing dynamic susceptibility contrast (DSC) determined relative cerebral blood volume (rCBV) and dynamic contrast enhancement (DCE) determined vascular permeability (derived transfer coefficient [Ktrans]).
SECONDARY OBJECTIVES:
I. Compare and evaluate magnetic resonance angiography (MRA) with ferumoxytol between different time points.
II. Assess number and size of tumors imaged. III. Assess tumor vascularity. IV. Assess histology and electron microscopy (EM) on tissue samples. V. Assess differences in subjects with prior therapy versus (vs.) no prior therapy (radiation and/or chemotherapy).
VI. Assess the long term imaging characteristics of different tumors using DSC and DCE.
OUTLINE:
Patients receive ferumoxytol non-stoichiometric magnetite intravenously (IV) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients also undergo MRI without contrast at baseline and on day 2. Imaging with ferumoxytol, GBCA, and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years.
After completion of study, patients are followed up at approximately 4-6 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (ferumoxytol, gadolinium, DCE-MRI, DSC-MRI) | Experimental | Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 Tesla Magnetic Resonance Imaging | Procedure | Undergo 3T MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans) | Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters Ktrans. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures. | Assessed after each visit for up to 6 imaging sessions (up to 5 years) |
| Utility of Ferumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Imaging Session by Comparing Dynamic Susceptibility Contrast (DSC) Determined Relative Cerebral Blood Volume (rCBV) Maps. | Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity). | Summarized after completion of up to 6 imaging sessions (up to 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume) | We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Enhancement volumes normalized to normal appearing white matter were calculated with histogram analysis. Enhancement cube root volumes were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. |
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Inclusion Criteria:
Subject must have either radiological or established histological diagnosis of the following general categories:
Previously untreated subjects must have a lesion on an imaging study
Post treatment subjects will have radiographic abnormalities that may or may not be recurrent tumor
Subjects agree to be contacted 4-6 weeks after each study visit
Subjects, or their legal guardian, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study treatment and for the duration of study treatment; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
Pre-imaging radiological scans/studies must be performed approximately 16 weeks prior to study entry; but not less than 24 hours prior
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 | Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium) | Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Procedure | Undergo 3T DCE-MRI |
|
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| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging | Procedure | Undergo 3T DSC-MRI |
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| Ferumoxytol | Drug | Given IV |
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| Gadolinium | Drug | Given IV |
|
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| MRI-Based Angiogram | Procedure | Undergo MRA |
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| Summarized after completion of up to 6 imaging sessions (up to 5 years) |
| Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity) | We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Signal intensities normalized to normal appearing white matter were calculated with histogram analysis. Signal intensities were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. Signal intensities were normalized to the signal intensity value of non-enhancing voxels inside the manual ROI (the relative complement of the final mask in Q, i.e. Q \ [A ∩ B ∩ C]). Higher values in signal intensity indicated increased image enhancement. | Summarized after completion of up to 6 imaging sessions (up to 5 years) |
| Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI | We evaluated overall survival in patients with pseudopregression or real tumor progression by using relative cerebral blood volume values on ferumoxytol enhanced perfusion MRIs. | Assessed after each visit for up to 6 imaging sessions (up to 5 years) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium) | Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA |
| Units | Counts |
|---|---|
| Participants |
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| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type of brain malignancy | Count of Participants | 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 | Utility of Femumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Session by Comparing Dynamic Contrast Enhanced Determined Vascular Permeability (Ktrans) | Appropriate descriptive statistics (mean, standard deviation, minimum, median, and maximum) will be estimated for the imaging parameters Ktrans. Frequency distributions of each parameter will also be described to assess normality. Pearson's correlation coefficients will be estimated to describe potential relationships among these various measures. | Software to derive K trans values from acquired images is not available and enhancement comparison between gadolinium and ferumoxytol K trans values is not possible to date. | Posted | Assessed after each visit for up to 6 imaging sessions (up to 5 years) |
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| Primary | Utility of Ferumoxytol and Gadolinium Based Contrast Agents for Improved Imaging Biomarkers of Malignant Brain Tumors in a Single Imaging Session by Comparing Dynamic Susceptibility Contrast (DSC) Determined Relative Cerebral Blood Volume (rCBV) Maps. | Compare rCBV measurements in regions of interest obtained from ferumoxytol DSC-MRI with gadolinium based contrast agent (GBCA) MR images to evaluate vascular properties of brain tumors. CBV maps were generated by applying tracer kinetic model to the first pass of the contrast bolus. Voxelwise CBV maps were coregistered to T1 weighted images and then normalized by dividing by the mean of normal appearing white matter CBV in the same region in the contralateral hemisphere. RCBV values (as the area under the signal intensity curve, normalized by the area under the curve for the control region) were obtained. Values range from 0 (low intensity) to 180 (highest intensity). | Posted | Mean | Full Range | Values on a scale | Summarized after completion of up to 6 imaging sessions (up to 5 years) |
| ||||||||||||||||||
| Secondary | Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Cube Root Volume) | We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Enhancement volumes normalized to normal appearing white matter were calculated with histogram analysis. Enhancement cube root volumes were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. | 58 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome. | Posted | Mean | Standard Deviation | mm | Summarized after completion of up to 6 imaging sessions (up to 5 years) | MR images/scans | MR images/scans |
| |||||||||||||||
| Secondary | Compare Number and Size of Tumors Imaged With Ferumoxytol and Gadolinium Based Contrast Agents (Signal Intensity) | We analyzed 193 sets of post-gadoteriol and 24 hours post-ferumoxytol T1 weighted scans from 58 patient with high grade glioma. Signal intensities normalized to normal appearing white matter were calculated with histogram analysis. Signal intensities were compared between the two contrast agents. Ferumoxytol and gadolinium enhanced MR images were obtained from each participant. Signal intensities were normalized to the signal intensity value of non-enhancing voxels inside the manual ROI (the relative complement of the final mask in Q, i.e. Q \ [A ∩ B ∩ C]). Higher values in signal intensity indicated increased image enhancement. | 58 participants had both appropriate ferumoxytol and gadolinium scans available for analysis for this outcome. | Posted | Mean | Standard Deviation | ratio | Summarized after completion of up to 6 imaging sessions (up to 5 years) | Images | Images |
| |||||||||||||||
| Secondary | Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI | We evaluated overall survival in patients with pseudopregression or real tumor progression by using relative cerebral blood volume values on ferumoxytol enhanced perfusion MRIs. | 68 participants had appropriate ferumoxytol scans available for analysis for this outcome. | Posted | Median | 95% Confidence Interval | months | Assessed after each visit for up to 6 imaging sessions (up to 5 years) |
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Subjects were evaluated for adverse events approximately 4-6 weeks after each study visit, up to 5 years.
Patients are monitored for adverse events in the scanning unit for the entire MRI time and 30 minutes after the final infusion of ferumoxytol An additional phone follow up visit was performed 4-6 weeks after each imaging session to focus on any new adverse events
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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 | Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium) | Study patients: adult patients with high grade primary malignant brain tumors Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA | 119 | 155 | 0 | 152 | 12 | 152 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerda Teglassy, MD | Oregon Health and Science University | 5034945626 | tothg@ohsu.edu |
| ID | Term |
|---|---|
| D005910 | Glioma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|
| Anaplastic Oligodendroglioma |
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| Primary CNS Lymphoma |
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| Brain metastasis |
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| Other |
|
| Unknown |
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|
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| OG001 | Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI | Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA |
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| OG001 | Malignant Brain Tumor Patients Undergoing Brain- Ferumoxytol-enhanced MRI | Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA |
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| Participants |
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