Ferumoxytol- and Gadolinium-Labeled MRI in Measuring Tumors Before or After Treatment in Patients With Primary or Metastatic Brain Tumors
Condition: Metastatic Malignant Neoplasm in the Brain; Primary Brain Neoplasm
MeSH terms: Neoplasms; Brain Neoplasms
Intervention: 3 Tesla Magnetic Resonance Imaging; Dynamic Contrast-Enhanced Magnetic Resonance Imaging; Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging; Ferumoxytol; Gadolinium; High Field Strength Magnetic Resonance Imaging; Susceptibility Weighted Imaging
Intervention description: Undergo 3T MRI; Undergo DCE MRI; Undergo DSC MRI; Given IV; Given IV; Undergo 7T MRI; Undergo SWI
Intervention MeSH terms: Ferrosoferric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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