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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01015 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 13-01-047 | Other Identifier | Albert Einstein College of Medicine | |
| P30CA013330 | U.S. NIH Grant/Contract | View source |
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IRB approved but never implemented
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies how well voxel based diffusion tensor imaging in predicting response in patients with brain metastases undergoing whole-brain radiation therapy or stereotactic radiosurgery. Voxel based diffusion tensor imaging (VB-DTI) may allow doctors to measure response to whole brain radiation therapy or stereotactic radiosurgery earlier than is possible with a standard magnetic resonance imaging. The earlier ability to measure response may allow for consideration of alternative therapies at an earlier stage.
PRIMARY OBJECTIVES:
I. To determine if voxel based diffusion tensor imaging will provide an early predictive assessment of therapy response, as compared to radiographic volumetric response criteria.
OUTLINE:
Patients undergoing whole-brain radiation therapy (WBRT) for a total of 10 fractions also undergo VB-DTI magnetic resonance imaging (MRI) at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing stereotactic radiosurgery (SRS) without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS.
After completion of study, patients are followed up every 2 months for 6 months and then every 6 months until death.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (VB-DTI, MRI) | Experimental | Patients undergoing WBRT for a total of 10 fractions also undergo VB-DTI MRI at baseline, 1 week after WBRT initiation, and 7-11 days after completion of WBRT. Patients undergoing SRS without WBRT also undergo VB-DTI MRI at baseline and 7-11 days after completion of SRS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diffusion tensor imaging | Procedure | Undergo VB-DTI |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of voxel-based mean apparent diffusion coefficient (ADC) increase per lesion | Up to 3 years | |
| Volume fraction of voxels showing treatment-related VB-DTI changes for each lesion | Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05. | At 4 months |
| Volumetric radiographic response for each lesion | Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05. Statistical significance will be achieved with a p value < 0.05. | At 4 months |
| Change in a lesion's overall mean ADC | Spearman's rank analysis will be used to determine if a correlation exists between the volume fraction of voxels showing treatment-related VB-DTI changes and the volumetric radiographic response for each lesion. Statistical significance will be achieved with a p value < 0.05. Statistical significance will be achieved with a p value < 0.05. | Baseline to 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhur Garg | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
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| whole-brain radiation therapy |
| Radiation |
Undergo WBRT |
|
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| stereotactic radiosurgery | Radiation | Undergo SRS |
|
| contrast-enhanced magnetic resonance imaging | Procedure | Undergo contrast-enhanced MRI |
|
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| diffusion-weighted magnetic resonance imaging | Procedure | Undergo DW MRI |
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|
| 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 |
| D016634 | Radiosurgery |
| 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 |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
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