Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-16

Study Completion Date

2020-12-31

Brief Summary

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This phase II trial studies how well magnetic resonance imaging (MRI) using contrast imaging agent ferumoxytol works in comparison to standard imaging agent gadolinium in measuring tumors in patients undergoing treatment for brain tumors or other tumors that have spread to the brain. Diagnostic procedures, such as MRI, may help find and diagnose disease and find out how far the disease has spread. MRI scans use radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. The contrast imaging agent ferumoxytol consists of small iron particles taken by the blood stream to the brain and to the area of the tumor. It is highly visible on the MRI, and may help visualize the blood flow going through the tumor better than gadolinium can. Using a more sensitive and faster 7 Tesla (7T) magnet MRI in conjunction with a contrast imaging agent may provide a better way to measure tumors than the 3 Tesla (3T) magnet MRI in patients with brain tumors.

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Detailed Description

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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.

Conditions

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Metastatic Malignant Neoplasm in the Brain Primary Brain Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

3 Tesla Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo 3T MRI

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo DCE MRI

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo DSC MRI

Ferumoxytol

Intervention Type DRUG

Given IV

Gadolinium

Intervention Type DRUG

Given IV

High Field Strength Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo 7T MRI

Susceptibility Weighted Imaging

Intervention Type PROCEDURE

Undergo SWI

Interventions

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3 Tesla Magnetic Resonance Imaging

Undergo 3T MRI

Intervention Type PROCEDURE

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Undergo DCE MRI

Intervention Type PROCEDURE

Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging

Undergo DSC MRI

Intervention Type PROCEDURE

Ferumoxytol

Given IV

Intervention Type DRUG

Gadolinium

Given IV

Intervention Type DRUG

High Field Strength Magnetic Resonance Imaging

Undergo 7T MRI

Intervention Type PROCEDURE

Susceptibility Weighted Imaging

Undergo SWI

Intervention Type PROCEDURE

Other Intervention Names

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3 Tesla MRI 3T MRI DCE MRI DCE-MRI DYNAMIC CONTRAST ENHANCED MRI DSC-MRI Dynamic Susceptibility Contrast-Enhanced MRI DYNAMIC SUSCEPTIBILITY-CONTRAST MRI Feraheme Ferumoxytol Non-Stoichiometric Magnetite Gd High Field Strength MRI BOLD Venographic Imaging BOLD Venography SWI

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No