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NCT00103038 · OUTCOME

Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI

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.

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
Assessed after each visit for up to 6 imaging sessions (up to 5 years)

What was measured

We evaluated overall survival in patients with pseudopregression or real tumor progression by using relative cerebral blood volume values on ferumoxytol enhanced perfusion MRIs.

Analysis population: 68 participants had appropriate ferumoxytol scans available for analysis for this outcome.

Groups in this outcome

Malignant Brain Tumor Patients Undergoing Brain MRI

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Malignant Brain Tumor Patients Undergoing Brain MRI68

Reported measurements

Median survival in patients with pseudoprogression seen on Fe-MRI

Analysis denominator · Participants

GroupSource count
Malignant Brain Tumor Patients Undergoing Brain MRI24
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Malignant Brain Tumor Patients Undergoing Brain MRI34.7Not reported20.354.1Not reported
Median survival in patients with real progression seen on Fe-MRI

Analysis denominator · Participants

GroupSource count
Malignant Brain Tumor Patients Undergoing Brain MRI44
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Malignant Brain Tumor Patients Undergoing Brain MRI13.4Not reported11.119.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        20.3
        upper Limit
        54.1
        value
        34.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        24
      units
      Participants
    title
    Median survival in patients with pseudoprogression seen on Fe-MRI
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        11.1
        upper Limit
        19.5
        value
        13.4
    denoms
    1. counts
      1. group Id
        OG000
        value
        44
      units
      Participants
    title
    Median survival in patients with real progression seen on Fe-MRI
denoms
  1. counts
    1. group Id
      OG000
      value
      68
    units
    Participants
description
We evaluated overall survival in patients with pseudopregression or real tumor progression by using relative cerebral blood volume values on ferumoxytol enhanced perfusion MRIs.
dispersion Type
95% Confidence Interval
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
    OG000
    title
    Malignant Brain Tumor Patients Undergoing Brain MRI
param Type
MEDIAN
population Description
68 participants had appropriate ferumoxytol scans available for analysis for this outcome.
reporting Status
POSTED
time Frame
Assessed after each visit for up to 6 imaging sessions (up to 5 years)
title
Overall Survival in Participants With Pseudoprogression With or Real Tumor Progression Using Ferumoxytol Enchanced Perfusion MRI
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice