Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors
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ClinicalTrials.gov Identifier: NCT00659126 |
Recruitment Status :
Terminated
(Loss of funding)
First Posted : April 16, 2008
Last Update Posted : November 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Metastatic Malignant Neoplasm in the Brain Primary Brain Neoplasm | Procedure: 3 Tesla Magnetic Resonance Imaging Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Drug: Ferumoxytol Drug: Gadolinium Procedure: High Field Strength Magnetic Resonance Imaging Procedure: Susceptibility Weighted Imaging | Phase 2 |
PRIMARY OBJECTIVES:
I. To compare quantitative blood brain barrier permeability measurements (derived transfer coefficient [Ktrans]) of a standard gadolinium (Gd) MRI contrast agent at 3T and 7T using dynamic contrast enhancement (DCE) MRI.
II. To compare dynamic susceptibility contrast (DSC) based perfusion measures at 3T and 7T.
SECONDARY OBJECTIVES:
I. To describe the blood brain barrier permeability to ferumoxytol (ferumoxytol non-stoichiometric magnetite) and to a standard gadolinium-based MRI contrast agent using signal intensity changes as described above.
II. To describe cerebral blood volume (CBV) measurements obtained using a standard gadolinium MRI contrast agent and ferumoxytol.
III. To evaluate tumor microvascularity on susceptibility-weighted images (SWI).
IV. To describe the microscopic distribution of ferumoxytol particles in tissue removed from subjects undergoing surgery.
OUTLINE: Patients are assigned to 3T or 7T magnet within the subgroups.
Patients receive gadolinium intravenously (IV) on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2. Patients undergo anatomical MRI sequences with 3T or 7T at baseline and on days 1-3. Patients also undergo DSC MRI and DCE MRI on days 1-2. Day 1 and day 2 imaging sessions may be separated by up to 7 days.
After completion of study, patients are followed up at approximately 4-6 weeks.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 38 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | A Phase II Study of Ferumoxytol and Gadolinium Magnetic Resonance Imaging at 3T and 7T in Subjects With Primary or Metastatic Brain Tumors Either Before or After Therapy |
Actual Study Start Date : | November 16, 2006 |
Actual Primary Completion Date : | December 31, 2019 |
Actual Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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Experimental: Diagnostic (Gd, ferumoxytol, 3T or 7T MRI)
Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2. Patients undergo anatomical MRI sequences with 3T or 7T at baseline and on days 1-3. Patients also undergo DSC MRI and DCE MRI on days 1-2. Day 1 and day 2 imaging sessions may be separated by up to 7 days.
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Procedure: 3 Tesla Magnetic Resonance Imaging
Undergo 3T MRI
Other Names:
Procedure: Dynamic Contrast-Enhanced Magnetic Resonance Imaging Undergo DCE MRI
Other Names:
Procedure: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging Undergo DSC MRI
Other Names:
Drug: Ferumoxytol Given IV
Other Names:
Drug: Gadolinium Given IV
Other Name: Gd Procedure: High Field Strength Magnetic Resonance Imaging Undergo 7T MRI
Other Name: High Field Strength MRI Procedure: Susceptibility Weighted Imaging Undergo SWI
Other Names:
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- Contrast to noise ratio (CNR), in terms of normalized signal intensity changes, for T1-weighted MRI signal at 3T and 7T (gadolinium [Gd] T1-weighted magnetic resonance imaging [MRI] data only) [ Time Frame: Baseline to day 1 ]Paired sample t-tests will be used for primary descriptive comparisons. Secondary analyses will use a repeated measures analysis of variance (ANOVA) model to compare 3T and 7T while adjusting for other factors including tumor type, prior therapy, and, potentially, important baseline factors that differ between the subjects assigned to the two field strengths. Normality will be assessed graphically and, if needed, a transformation (e.g. the logarithmic transform) will be applied.
- CNR, in terms of normalized signal intensity changes, for dynamic susceptibility contrast (DSC) MRI data sets at 3T and 7T (ferumoxytol only) [ Time Frame: Day 2 to day 3 ]Paired sample t-tests will be used for primary descriptive comparisons. Secondary analyses will use a repeated measures ANOVA model to compare 3T and 7T while adjusting for other factors including tumor type, prior therapy, and, potentially, important baseline factors that differ between the subjects assigned to the two field strengths. Normality will be assessed graphically and, if needed, a transformation (e.g. the logarithmic transform) will be applied.
- Relevant dynamic MRI (dynamic contrast enhancement [DCE] and DSC) signal intensity changes for permeability and perfusion [ Time Frame: Day 1 to day 2 ]Mixed model repeated measures ANOVAs will be fit. Factors will include imaging agent (Gd or ferumoxytol) and field strength (3T and 7T). Each subject will contribute one measure for each combination of imaging agent and field strength (4 measures total).
- Change in cerebral blood volume (CBV) measurements, quantified using DSC techniques [ Time Frame: Day 1 to day 2 ]Blood volumes will be compared using repeated measures ANOVA to compare the imaging agents.
- Change in tumor microvascularity on susceptibility-weighted images (SWI) before and after ferumoxytol [ Time Frame: Day 2 to day 3 ]Analysis will also include covariates of prior therapy. For the comparisons between treated and untreated subjects, means and confidence intervals will be estimated for each group for the perfusion and permeability measures and for the baseline characteristics.
- Presence of iron staining [ Time Frame: At time of surgery ]The pathology will be analyzed qualitatively for the presence of iron staining. The amount and localization of the staining will be assessed, with attention paid to whether the tumor cells themselves or reactive cells in and around the tumor demonstrate iron uptake.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects with radiographically suspected, histologically or cytologically confirmed primary brain tumors or brain metastasis are eligible
- Subjects may be enrolled at any point in diagnosis or treatment
- Subjects must have had radiographically evaluable or measurable disease with standard magnetic resonance (MR) imaging
- Members of all races and ethnic groups will be included
- Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (Karnofsky performance status [KPS] >= 30)
- Ability to understand and the willingness to sign a written informed consent document, or have a representative able to consent for the subject
- 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
- Subject agrees to complete follow up visit
Exclusion Criteria:
- Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness
- Subjects who have a contraindication for MRI: metal in their bodies (a cardiac pacemaker or other incompatible device), are severely agitated, need monitored anesthesia for scanning, or have an allergy to Gd contrast material
- Subjects with known hepatic insufficiency or cirrhosis
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ferumoxytol
- Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
- Subjects expecting to undergo surgery between the imaging sessions; subjects may undergo surgery at any time before the first, or after the last imaging session; this exclusion only applies to each study visit (3 day scanning session), and does not apply to the time (at least 3 weeks) between each study visit
- Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or lactating women are excluded from this study
- Inability or unwillingness to undergo the complete series of imaging sessions; inability or unwillingness to complete the one month follow-up
- Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible
- Subjects with glomerular filtration rate (GFR) < 50
- Subjects with three or more drug allergies from separate drug classes

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659126
United States, Oregon | |
OHSU Knight Cancer Institute | |
Portland, Oregon, United States, 97239 |
Principal Investigator: | Edward Neuwelt | OHSU Knight Cancer Institute |
Responsible Party: | Edward Neuwelt, Principal Investigator, OHSU Knight Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00659126 |
Other Study ID Numbers: |
IRB00002864 NCI-2015-00225 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) SOL-06077-L IRB00002864 ( Other Identifier: OHSU Knight Cancer Institute ) R01CA137488 ( U.S. NIH Grant/Contract ) |
First Posted: | April 16, 2008 Key Record Dates |
Last Update Posted: | November 10, 2021 |
Last Verified: | November 2021 |
Neoplasms Brain Neoplasms Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms by Site Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Ferrosoferric Oxide Hematinics Parenteral Nutrition Solutions Pharmaceutical Solutions |