Digital Mammography, Ultrasound, MRI, and PET Scans in Women With Newly Diagnosed Breast Cancer

• Size of the index lesion (3 dimensions and tumor volume) [ Designated as safety issue: No ]
  
• Relative sensitivity/specificity of imaging in identifying additional cancer foci at least 2 cm from the index lesion margin [ Designated as safety issue: No ]
  
• Relative yield of imaging in detecting lymph node and distant metastases [ Designated as safety issue: No ]
  

• Positive predictive value of imaging-identified suspicious incidental lesions [ Designated as safety issue: No ]
  
• Negative predictive value of imaging (compared to mastectomy sectioning) for identifying unifocal disease [ Designated as safety issue: No ]
  
• Imaging features predictive of lymph node status [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the ability of digital mammography, ultrasound, MRI, and fludeoxyglucose F 18 positron emission tomography (FDG-PET) in depicting the extent of the index lesion within an affected breast in women with newly diagnosed breast cancer.
• Compare the ability of digital mammography, ultrasound, MRI, and FDG-PET in identifying additional foci of cancer in the affected breast.
• Estimate the accuracy of FDG-PET in predicting the status of the axillary lymph nodes, using sentinel node sampling as the gold standard.
• Determine whether diffuse or multifocal cancers detected on MRI, ultrasound, digital mammography, and FDG-PET can be predicted based on mammographic, clinical, or pathologic findings.
• Based on correlation of various imaging techniques and clinical and pathological findings, generate a profile of patients at risk for mammographically and clinically occult, diffuse or multifocal disease.
• Collect pilot data on the accuracy of digital tomosynthesis in determining the extent of breast cancer (in women consenting to the contrast-enhanced tomosynthesis study).

OUTLINE: This is a prospective study. Patients are stratified according to breast density (fatty vs scattered/less than 50% dense vs heterogeneously dense/greater than 50% dense vs extremely dense), presentation (palpable abnormalities vs imaging abnormalities only), and image findings (density vs calcification).

Patients undergo MRI, ultrasound, digital mammography, and fludeoxyglucose F 18 positron emission tomography. Results of imaging are compared by a panel of physicians to determine efficacy of each method. Consenting patients also undergo digital tomosynthesis with or without contrast enhancement.

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.