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Trial closed due to low accrual
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This is a pilot study to assess the changes in white matter, in the brain, in response to radiation therapy and correlate these changes with later declines in cognitive function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary Brain Tumor | Other | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Radiotherapy | Radiation | Standard cranial radiotherapy administered dependent upon patient and brain tumor type. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy. | 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. | Baseline, 3 weeks, and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carl Koschmann, M.D. | University of Michigan Rogel Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Cancer Center | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| MRI with Diffusion Tensor Imaging (DTI) | Device | Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) |
|
| Neuro-cognitive Testing (CogState) | Behavioral | CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests. |
|
| Baseline, 3 weeks, and 6 weeks |
| Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months | 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. | 6 months |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Gender | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Evaluate the Change From Baseline in Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging (DTI) at 3 Weeks and at 6 Weeks Post Radiation Therapy. | 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. | 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 | Posted | Baseline, 3 weeks, and 6 weeks |
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| Secondary | Evaluate the Correlation Between Global COGState Scores and the Perpendicular Diffusivity of Water by Diffusion Tensor Imaging at Baseline, 3 Weeks, and 6 Weeks Into Treatment. | 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. | Data can not be accessed due to technical difficulties with the COGState server. | Posted | Baseline, 3 weeks, and 6 weeks |
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| Secondary | Evaluate the Correlation Between Global COGState Scores, Radiation Dose, and the Perpendicular Diffusivity of Water as Measured by Diffusion Tensor Imaging at 6 Months | 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. | Data can not be accessed due to technical difficulties with the COGState server. | Posted | 6 months |
|
Data on adverse events were collected from the time of the initial study intervention through the 12 month post baseline visit.
Only events related to the study intervention (MRI and Neuro-cognitive Testing) were reported. No adverse events related to these interventions were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carl Johannes Koschmann, M.D. | University of Michigan Comprehensive Cancer Center | 734-647-2893 | ckoschma@umich.edu |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D056324 | Diffusion Tensor Imaging |
| ID | Term |
|---|---|
| D059906 | Neuroimaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D038524 | Diffusion Magnetic Resonance Imaging |
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003943 | Diagnostic Techniques, Neurological |
| D008919 | Investigative Techniques |
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