An interventional study of Gadolinium and Ferumoxytol Non-Stoichiometric Magnetite in Adult Brain Glioblastoma, sponsored by OHSU Knight Cancer Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by OHSU Knight Cancer Institute · Not applicable, Interventional, and Diagnostic
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 14 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →OHSU Knight Cancer Institute is the lead sponsor of 242 studies on the registry; 45 are open to participants now.
Of its 27 completed or terminated interventional studies of FDA-regulated products, 15 (56%) have results posted.
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Exclusion Criteria:
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.
Drug: Ferumoxytol Non-Stoichiometric Magnetite · Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging · Other: Diffusion Weighted Imaging · Other: MRI-Based Angiogram
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).
Drug: Gadolinium · Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging · Other: Diffusion Weighted Imaging · Other: MRI-Based Angiogram
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).
Drug: Gadolinium · Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging · Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging · Other: Diffusion Weighted Imaging · Other: MRI-Based Angiogram
Given IV
Also known as: Gd
Given IV
Also known as: Fe3O4, Feraheme, Ferumoxytol
Undergo DCE MRI
Also known as: DCE MRI, DCE-MRI
Undergo DSC MRI
Also known as: DSC-MRI, Dynamic Susceptibility Contrast-Enhanced MRI
Undergo DWI
Also known as: Diffusion Weighted MRI, DWI, DWI MRI, DWI-MRI
Undergo TOF MR angiography
Also known as: Magnetic Resonance Angiogram, MRA
Mean Cerebral Blood Volume (CBV)
Radiographical progression is determined based on RANO criteria.
Time frame: 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).
Time frame: Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.
| Milestone | Gadoteridol + Ferumoxytol Contrast Agent |
|---|---|
| Started | 14 |
| Completed | 14 |
| Not completed | 0 |
Radiographical progression is determined based on RANO criteria.
| mL/g | Ferumoxytol | Gadoteridol | Gadoteridol Leakage Correction |
|---|---|---|---|
| Mean Cerebral Blood Volume (CBV) | 2.5 ± 2.1 | 1.38 ± 1.73 | 2.36 ± 1.94 |
Tumor progression was assessed by RANO criteria (Wen, 2010).
| participants | Tumor Progression on Conventional MR |
|---|---|
| Tumor Progression on Conventional MR | 14 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ferumoxytol | — | 0/14 (0%) | 1/14 (7.1%) |
| Gadoteridol | — | 0/14 (0%) | 0/14 (0%) |
| Gadoteridol With Leakage Correction | — | 0/14 (0%) | 0/14 (0%) |
| Event | Ferumoxytol | Gadoteridol | Gadoteridol With Leakage Correction |
|---|---|---|---|
| NauseaGastrointestinal disorders | 1/14 | 0/14 | 0/14 |
| Age, Categorical(Participants) | Gadoteridol + Ferumoxytol Contrast Agent |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 5 |
| Age, Continuous(years) | Gadoteridol + Ferumoxytol Contrast Agent |
|---|---|
| Mean | 60 (43 to 81) |
| Sex: Female, Male(Participants) | Gadoteridol + Ferumoxytol Contrast Agent |
|---|---|
| Female | 5 |
| Male | 9 |
| Region of Enrollment(participants) | Gadoteridol + Ferumoxytol Contrast Agent |
|---|---|
| United States | 14 |
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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