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NCT00103038 · FLOW

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Ferumoxytol in Improving MR Imaging in Patients With High-Grade Brain Tumors or Cerebral Metastases · Source last updated 2022-06-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA
    id
    FG000
    title
    Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Screen failure
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        142
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Overall Study
Complete source fields
groups
  1. description
    Study patients: adult patients with high grade primary malignant brain tumors or with known or suspected brain metastases from histologically confirmed primary cancer Study procedures: patients will receive IV ferumoxytol (maximum dose 4 mg/kg, over at least 15 minutes) beginning approximately 15 seconds after start of 3T DSC-MRI and GBCA IV approximately 1 minute and 50 seconds after start of 3T DCE-MRI on day 1. Patients will also undergo MRI without contrast at baseline (before and on day 2. Imaging with ferumoxytol, GBCA and without contrast repeats every 3 weeks for a total of 6 more imaging sessions over up to 5 years. 3 Tesla Magnetic Resonance Imaging: Undergo 3T MRI Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DCE-MRI Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo 3T DSC-MRI Ferumoxytol: Given IV Gadolinium: Given IV MRI-Based Angiogram: Undergo MRA
    id
    FG000
    title
    Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        8
      type
      Withdrawal by Subject
    2. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Screen failure
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    4. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Physician Decision
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        155
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        142
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        13
      type
      NOT COMPLETED
    title
    Overall Study

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Preserved source evidence · Not medical advice