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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
\[18F\]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.
The University of Alabama at Birmingham
Birmingham, Alabama, United States
Baseline measure of PET standardized uptake value (SUV).
Compare baseline metrics from PET/MRI
Time frame: Baseline imaging visit 1
Baseline measure of apparent diffusion coefficient (ADC) in mm2/sec from MRI.
Compare baseline metrics from PET/MRI
Time frame: Baseline imaging visit 1
Baseline measure of signal enhancement ratio (SER) from MRI.
Compare baseline metrics from PET/MRI
Time frame: Baseline imaging visit 1
Changes in SER from MRI
Compare percent change of SER from imaging visit 3 to the baseline.
Time frame: Baseline through 6 months
Changes in ADC from MRI
Compare percent change of ADC (mm2/sec) from imaging visit 3 to the baseline.
Time frame: Baseline through 6 months
Changes in SUV from PET
Compare percent change of SUV from imaging visit 3 to the baseline.
Time frame: Baseline through 6 months
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).
Time frame: Baseline through 5 year follow-up
Changes in ADC (mm2/sec) from MRI.
Compare percent change from imaging visit 2 to the baseline.
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Time frame: Baseline through 2 months
Changes in SER from MRI.
Compare percent change from imaging visit 2 to the baseline.
Time frame: Baseline through 2 months
Changes in SUV from PET.
Compare percent change from imaging visit 2 to the baseline.
Time frame: Baseline through 2 months