Trial Outcomes & Findings for A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors (NCT NCT02006407)
NCT ID: NCT02006407
Last Updated: 2016-12-30
Results Overview
Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.
TERMINATED
NA
5 participants
Baseline, 3 weeks, and 6 weeks
2016-12-30
Participant Flow
Participant milestones
| Measure |
Primary Brain Tumor
Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests.
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|---|---|
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Overall Study
STARTED
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5
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Overall Study
COMPLETED
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5
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pilot Study to Evaluate Neurocognitive Injury and Longitudinal Changes in White Matter During Radiation Therapy in Children With Primary Brain Tumors
Baseline characteristics by cohort
| Measure |
Primary Brain Tumor
n=5 Participants
Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).
Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests.
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|---|---|
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Age, Continuous
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14 years
n=5 Participants
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Gender
Female
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2 Participants
n=5 Participants
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Gender
Male
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3 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline, 3 weeks, and 6 weeksPopulation: Because the outcome measure was CHANGE FROM BASELINE to 3 and 6 weeks, and data were not able to be collected at 3 and 6 weeks, the outcome measure could not be analyzed
Descriptive statistics and plots will be used to determine Diffusion Tensor Imaging (DTI) parameters for various regions in the brain. The mean (across subject) change in DTI parameter for a given region, at a given time, will be used to assess white matter injury.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, 3 weeks, and 6 weeksPopulation: Data can not be accessed due to technical difficulties with the COGState server.
Determine the change in cognitive test scores from baseline to time-points early during radiation therapy (3 and 6 weeks) using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will be measurable even in this acute setting and will correlate with global response as measured on COGState with the sub-domains on executive function anticipated to be most highly correlated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: Data can not be accessed due to technical difficulties with the COGState server.
Determine the change in cognitive test scores from baseline, at 6 months using CogState (a computerized software testing system that offers various cognitive assessments based on expansive neurocognitive tests). Correlate test scores from COGState with changes in Diffusion Tensor Imaging (DTI) at the same timepoints (Baseline and 6 months) using scatter plots with Pearson and Spearman's correlation coefficients. As a pilot study multiple comparisons will be assessed; however, the working hypothesis based upon results in adults treated with radiation therapy is that DTI changes as measured by an increase in diffusivity of water perpendicular to the direction of axonal transport will correlate with changes in global response as measured on COGState with the sub-domains on executive function most highly correlated. In addition, these regional changes in DTI will be directly related to the radiation doses received in these regions.
Outcome measures
Outcome data not reported
Adverse Events
Primary Brain Tumor
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carl Johannes Koschmann, M.D.
University of Michigan Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place