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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-00224 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| SOL-06062-LX | |||
| 813 | |||
| NCI-2015-00204 | |||
| 8097 | |||
| 2753 | Other Identifier | OHSU Knight Cancer Institute | |
| P30CA069533 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies how a magnetic resonance imaging (MRI) study with ferumoxytol works as a contrasting agent in assessing early response in patients with glioblastoma multiforme receiving temozolomide and radiation therapy. Ferumoxytol is a very small form of iron particles that are injected into the body and taken up by certain tissues which may make these tissues easier to see during imaging. Diagnostic procedures, such as an MRI study with ferumoxytol, may help measure a patient's response to earlier treatment.
PRIMARY OBJECTIVES:
I. To characterize glioblastoma multiforme (GBM) tumor vascular properties using ferumoxytol (ferumoxytol non-stoichiometric magnetite) and compare to those obtained using gadolinium (Gd) based MRI contrast agent.
II. To characterize vascular changes in GBM tumors associated with standard radio/chemotherapy.
SECONDARY OBJECTIVES:
I. Cerebral blood flow (CBF), mean transit time (MTT), and time-to-peak (TTP) perfusion parameters will be measured for each contrast agent and evaluated in post-hoc analysis.
II. To obtain qualitative assessment of tumor vascularity using time-of-flight (TOF) magnetic resonance (MR) angiography techniques.
III. To characterize changes in the apparent diffusion coefficient (ADC) of tumor water associated with standard radio/chemotherapy in GBM.
OUTLINE:
Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo dynamic susceptibility contrast enhanced (DSC) MRI, and dynamic contrast enhanced (DCE) MRI, diffusion-weighted imaging (DWI) (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. Patients also receive temozolomide and undergo radiation therapy per standard of care.
After completion of ferumoxytol non-stoichiometric magnetite administration, patients are followed up for 4-6 weeks and then periodically until the resolution or stabilization of unacceptable toxicities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol | Experimental | Patients receive ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). Ferumoxytol non-stoichiometric magnetite administration continues in the absence of unacceptable toxicity. |
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| Gadoteridol | Active Comparator | Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). |
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| Gadoteridol Leakage Corrected | Active Comparator | Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gadolinium | Drug | Given IV |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Cerebral Blood Volume (CBV) | Radiographical progression is determined based on RANO criteria. | At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation) |
| Tumor Progression on Conventional MR | Tumor progression was assessed by RANO criteria (Wen, 2010). | Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation. |
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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 | Gadoteridol + Ferumoxytol Contrast Agent | Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points. |
| Title | Milestones | Reasons Not Completed | |||||
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| Overall Study |
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| Ferumoxytol Non-Stoichiometric Magnetite | Drug | Given IV |
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| Dynamic Contrast-Enhanced Magnetic Resonance Imaging | Other | Undergo DCE MRI |
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| Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging | Other | Undergo DSC MRI |
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| Diffusion Weighted Imaging | Other | Undergo DWI |
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| MRI-Based Angiogram | Other | Undergo TOF MR angiography |
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| ID | Title | Description |
|---|---|---|
| BG000 | Gadoteridol + Ferumoxytol Contrast Agent | Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points. |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Mean Cerebral Blood Volume (CBV) | Radiographical progression is determined based on RANO criteria. | All patients with treated GMB showed apparent tumor progression on conventional MR images. | Posted | Mean | Standard Deviation | mL/g | At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation) |
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| Primary | Tumor Progression on Conventional MR | Tumor progression was assessed by RANO criteria (Wen, 2010). | Posted | Number | participants | Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation. |
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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 | Ferumoxytol | Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points | 0 | 14 | 1 | 14 | ||
| EG001 | Gadoteridol | Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points | 0 | 14 | 0 | 14 | ||
| EG002 | Gadoteridol With Leakage Correction | Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points | 0 | 14 | 0 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Edward Neuwelt | Oregon Health and Science University | 503-494-5626 | neuwelte@ohsu.edu |
| ID | Term |
|---|---|
| D005682 | Gadolinium |
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D028581 | Lanthanoid Series Elements |
| D008674 | Metals, Rare Earth |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D005296 | Ferrous Compounds |
| D008903 | Minerals |
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Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.
| .008 |
| Superiority or Other |
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