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NCT00602667 · OUTCOME

Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe

Risk-Adapted Therapy for Young Children With Embryonal Brain Tumors, Choroid Plexus Carcinoma, High Grade Glioma or Ependymoma · Source last updated 2026-05-19

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

Measure
NUMBER
Unit
Change in FA per month
Interval / dispersion
95% Confidence Interval
Time frame
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)

What was measured

Quantitative MRI measures Fractional Anisotropy (FA) change per month in frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy. Fractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1

Analysis population: Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.

Groups in this outcome

Low-Risk Group

Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma

Intermediate-Risk Group

Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease

High-Risk Group

Patients with central nervous system (CNS) metastatic disease

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

Analysis denominator · Participants

GroupSource count
Low-Risk Group12
Intermediate-Risk Group43
High-Risk Group20

Reported measurements

Source class 1
Values in Change in FA per month · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Low-Risk Group0.0019Not reported0.00160.0022Not reported
Intermediate-Risk Group0.0017Not reported0.00150.0018Not reported
High-Risk Group0.0017Not reported0.00140.0019Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0016
        upper Limit
        0.0022
        value
        0.0019
      2. group Id
        OG001
        lower Limit
        0.0015
        upper Limit
        0.0018
        value
        0.0017
      3. group Id
        OG002
        lower Limit
        0.0014
        upper Limit
        0.0019
        value
        0.0017
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      43
    3. group Id
      OG002
      value
      20
    units
    Participants
description
Quantitative MRI measures Fractional Anisotropy (FA) change per month in frontal lobe over time in each risk group will be assessed using a random effects model incorporating various covariates. Covariates to be considered include age at diagnosis, time since diagnosis and risk-arm. Differences in quantitative MRI measures of neurostructure volume and integrity between patient groups will be evaluated as a metric of structural neurotoxicity of therapy. Fractional anisotropy (FA) is a scalar unitless measure that quantifies the degree of anisotropy of a diffusion process, particularly in the context of diffusion tensor imaging (DTI) used in MRI scans. FA values range from 0 to 1
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients with gross total resection (GTR)/no evidence of metastatic disease (M0) medulloblastoma, nodular desmoplastic histology, or high grade glioma
    id
    OG000
    title
    Low-Risk Group
  2. description
    Patients with no evidence of metastatic disease (M0) medulloblastoma or nodular desmoplastic histology with less than a gross total resection (GTR), other histologic diagnoses with no metastatic disease
    id
    OG001
    title
    Intermediate-Risk Group
  3. description
    Patients with central nervous system (CNS) metastatic disease
    id
    OG002
    title
    High-Risk Group
param Type
NUMBER
population Description
Eligible infratentorial medulloblastoma, ependymoma, and pineoblastoma patients(n=75) were included.
reporting Status
POSTED
time Frame
From baseline (month 0) to 60 months (therapy duration lasted approximately 48 weeks or 11 months)
title
Change in Quantitative Magnetic Resonance (MR) Measures in the Frontal Lobe
type
SECONDARY
unit Of Measure
Change in FA per month

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice