This clinical trial studies positron emission tomography (PET)/computed tomography (CT) or PET/magnetic resonance imaging (MRI) in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer. New diagnostic procedures, such as PET/CT or PET/MRI, may be more effective than MRI alone in measuring tumors in patients undergoing clinical imaging or with newly diagnosed breast cancer.
PRIMARY OBJECTIVES: I. To improve visualization of tumors by developing better image reconstruction and correction methods. II. To revise the positioning devices and, if necessary, scanner table to fit a wider size range of women. OUTLINE: Patients undergo clinical fludeoxyglucose F-18 (FDG)-PET/CT followed by prone breast PET/CT and/or prone breast PET/MRI with or without gadopentetate dimeglumine (DTPA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
43
Undergo PET/CT
Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Attenuation Correction for PET/MRI, Assessed Using Standard Uptake Values (SUVs) (Cohorts I & II)
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Time frame: 1 yr from study start
Attenuation Correction for PET/CT, Assessed Using SUVs (Cohorts I & II)
Uptake and attenuation correction of PET/MRI and PET/CT will be examined by comparing SUVs of the two methods. The proportions of subjects with SUV of the PET/MR within 5%, 10%, and 20% of the SUV from PET/CT will be estimated with exact 95% confidence intervals.
Time frame: 1 yr from study start
Comparison of Specificity Rates of Fused FDG-PET/MRI (Cohort III)
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare specificity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest specificity. Single parameter: DCE-MRI is the gold standard to which the two parameter and three parameter rows are compared. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET
Time frame: 1 yr from study start
Sensitivity of PET/CT and PET/MRI (Cohort III)
McNemar's test or a generalized estimating equations logistic regression model with patient as the cluster used to compare sensitivity rates of the new technology versus current technology (MRI alone), restricting analysis to true negative lesions. Utilizing 3 different combinations of scan parameters to determine which combination has the highest sensitivity. Combinations include: Single parameter: DCE-MRI Two Parameter A: DCE-MRI and DWI ADC Two Parameter B: DCE-MRI and FDG-PET Three Parameter: DCE-MRI, DWI ADC, FDG-PET
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Time frame: 1 yr from study start