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NCT00103038 · BASELINE

Baseline characteristics

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.

denoms
  1. counts
    1. group Id
      BG000
      value
      155
    units
    Participants
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
    BG000
    title
    Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.81
          value
          51.71
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          85
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          150
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          147
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        title
        Glioblastoma
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Anaplastic Astrocytoma
      3. measurements
        1. group Id
          BG000
          value
          19
        title
        Anaplastic Oligodendroglioma
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Primary CNS Lymphoma
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        Brain metastasis
      6. measurements
        1. group Id
          BG000
          value
          17
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          11
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of brain malignancy
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      155
    units
    Participants
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
    BG000
    title
    Malignant Brain Tumor Patients Undergoing Brain MRI (With Both Ferumoxytol and Gadolinium)
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          spread
          13.81
          value
          51.71
    dispersion Type
    STANDARD_DEVIATION
    param Type
    MEAN
    title
    Age, Continuous
    unit Of Measure
    years
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          70
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          85
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Hispanic or Latino
      2. measurements
        1. group Id
          BG000
          value
          150
        title
        Not Hispanic or Latino
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Ethnicity (NIH/OMB)
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        American Indian or Alaska Native
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Asian
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        Native Hawaiian or Other Pacific Islander
      4. measurements
        1. group Id
          BG000
          value
          1
        title
        Black or African American
      5. measurements
        1. group Id
          BG000
          value
          147
        title
        White
      6. measurements
        1. group Id
          BG000
          value
          0
        title
        More than one race
      7. measurements
        1. group Id
          BG000
          value
          2
        title
        Unknown or Not Reported
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race (NIH/OMB)
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          67
        title
        Glioblastoma
      2. measurements
        1. group Id
          BG000
          value
          19
        title
        Anaplastic Astrocytoma
      3. measurements
        1. group Id
          BG000
          value
          19
        title
        Anaplastic Oligodendroglioma
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Primary CNS Lymphoma
      5. measurements
        1. group Id
          BG000
          value
          18
        title
        Brain metastasis
      6. measurements
        1. group Id
          BG000
          value
          17
        title
        Other
      7. measurements
        1. group Id
          BG000
          value
          11
        title
        Unknown
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Type of brain malignancy
    unit Of Measure
    Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice