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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Grant/Funding Number | UAB Comprehansive Cancer Center and Department of Radiology |
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Unable to recruit for this study.
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The purpose of the study is to see if a new group of imaging tests can help identify response to stage IV HER2+ breast cancer before treatment.
The purpose of this study is to see if a new group of imaging tests can help identify response to stage IV human epidermal growth factor receptor 2 positive (HER2+) breast cancer before and during treatment. This study will test a new method for monitoring treatment. The investigators will use [18F]-Fluorodeoxyglucose (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) to look at previously diagnosed stage IV breast cancer and image up to three times during therapy. FDG is a non-natural amino acid with a radioactive tag that is used clinically for staging of disease. However, the role of FDG-PET/MRI for imaging response in breast cancer is not currently clear. PET/MRI is a new imaging technique that combines PET and MRI into a single study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [18F]-Fluorodeoxyglucose (FDG) PET/ MRI | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-FDG | Drug | [18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Baseline measure of PET standardized uptake value (SUV). | Compare baseline metrics from PET/MRI | Baseline imaging visit 1 |
| Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI. | Compare baseline metrics from PET/MRI | Baseline imaging visit 1 |
| Baseline measure of signal enhancement ratio (SER) from MRI. | Compare baseline metrics from PET/MRI | Baseline imaging visit 1 |
| Changes in SER from MRI | Compare percent change of SER from imaging visit 3 to the baseline. | Baseline through 6 months |
| Changes in ADC from MRI | Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline. | Baseline through 6 months |
| Changes in SUV from PET | Compare percent change of SUV from imaging visit 3 to the baseline. | Baseline through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Follow-up | Compare changes in imaging metrics to disease progression (defined as clinical progression of disease through increase in lesion size or increase in number of lesions). | Baseline through 5 year follow-up |
| Changes in ADC (mm2/sec) from MRI. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Sorace, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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Compare percent change from imaging visit 2 to the baseline.
| Baseline through 2 months |
| Changes in SER from MRI. | Compare percent change from imaging visit 2 to the baseline. | Baseline through 2 months |
| Changes in SUV from PET. | Compare percent change from imaging visit 2 to the baseline. | Baseline through 2 months |