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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2014-01907 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| VICC NEU1424 | Other Identifier | Vanderbilt-Ingram Cancer Center | |
| P30CA068485 | U.S. NIH Grant/Contract | View source |
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Change in PI and funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This pilot clinical trial studies quantitative magnetic resonance imaging (MRI) at 3 Tesla in assessing disease in patients with tumors that have spread to the brain (brain metastases). In addition to routine care brain imaging of the brain, this study will include advanced multiparametric MRI sequences to measure vascular, cellular, and molecular properties of the tumor. Performing extra scans during MRI provides more information about the metastases and may better predict treatment response.
PRIMARY OBJECTIVES:
I. To correlate pre-treatment measures of biophysical parameters in metastases-obtained using advanced, quantitative MRI techniques in patients receiving standard-of-care (SOC) therapy for 1-4 brain metastases-with treatment-induced changes in lesion size, time-to-progression (TTP), and overall survival (OS).
OUTLINE:
Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, diffusion-weighted (DW)-MRI, chemical exchange saturation transfer (CEST), and combined dynamic contrast enhanced (DCE)-MRI/dynamic susceptibility contrast (DSC)-MRI at baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (hybrid MRI) | Experimental | Patients undergo hybrid 3 Tesla MRI examination that includes standard MRI sequences, DW-MRI, CEST, and combined DCE-MRI/DSC-MRI at baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| diffusion-weighted magnetic resonance imaging | Procedure | Undergo DW-MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Volume transfer constant (Ktrans), as measured by DCE-MRI | The ability of pre-treatment estimates of Ktrans to predict objective tumor response by Response Evaluation Criteria in Solid Tumors or Macdonald criteria after therapy will be assessed using the proportional odds model. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Amide proton transfer asymmetry (APTasym) as measured by CEST | Cox proportional hazards regression will be used to assess the association of APTasym with change in tumor size. | Baseline |
| Apparent diffusion coefficient (ADC), as measured by DW-MRI |
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Inclusion Criteria:
Patients must sign an Institutional Review Board (IRB)-approved informed consent document
Patients must have been diagnosed with one of the following:
Patients must have been diagnosed with 1-4 brain metastases
At least one of the brain metastases must measure 5 mm (or more) in short axis diameter in the axial plane
Patients must be scheduled to undergo standard brain cancer interventions:
Patients must be scheduled to receive a 3-Tesla (3T) MRI exam as part of their standard of care (this exam will be modified to also include pulse sequences with are for research only)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Attia, MD | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| chemical exchange saturation transfer magnetic resonance imaging | Procedure | Undergo CEST-MRI |
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| dynamic contrast-enhanced magnetic resonance imaging | Procedure | Undergo DCE-MRI |
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| dynamic susceptibility contrast-enhanced magnetic resonance imaging | Procedure | Undergo DSC-MRI |
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Cox proportional hazards regression will be used to assess the association of ADC with change in tumor size.
| Baseline |
| Extravascular extracellular volume fraction (Ve), as measured by DCE-MRI | Cox proportional hazards regression will be used to assess the association of Ve with change in tumor size. | Baseline |
| Plasma volume fraction (Vp), as measured by DCE-MRI | Cox proportional hazards regression will be used to assess the association of Vp with change in tumor size. | Baseline |
| Cerebral blood volume (CBV), as measured by DSC-MRI | Cox proportional hazards regression will be used to assess the association of CBV with change in tumor size. | Baseline |
| Cerebral blood flow (CBF), as measured by DSC-MRI | Cox proportional hazards regression will be used to assess the association of CBF with change in tumor size. | Baseline |
| Mean transit time (MTT), as measured by DSC-MRI | Cox proportional hazards regression will be used to assess the association of MTT with change in tumor size. | Baseline |
| 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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