Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer

• PEM identification of primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]
  

• Lowest dose of F18-FDG giving optimal PEM imaging of primary breast cancers. [ Time Frame: After the first 30 subjects (~one year) ] [ Designated as safety issue: No ]
  
• Identification of 2nd unsuspected primary breast cancer by PEM in patients with known index primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]
  
• Comparison of PEM and MRI for identification of index primary breast cancer and unsuspected primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]
  
• Comparison of PEM and MRI for identification of breast lesions that require biopsy but are not an unsuspected 2nd primary breast cancer in patients with known index primary breast cancer. [ Time Frame: Upon study completion (~3 years) ] [ Designated as safety issue: No ]
  

The purpose of this research in Phase 1 is to determine the lowest dose of radionuclide 18F-FDG that can be used in the Diagnostic use of Positron Emission Mammography for the diagnosis of multifocal breast cancer in patients wishing to have Breast Conservation Surgery for newly diagnosed breast cancer. Low dose injections (radioactive counts) of 18F-FDG will be compared to the equivalent radioactive counts for the standard higher dose 10 millicuries used in standard PEM studies in current clinical practice. Images will be post processed by computer aided software and will be placed in two categories: Low dose group, and higher dose group. Images will be randomly blinded to readers to assess the ability to see positive lesions that warrant further biopsy or to include in current surgical planning prior to breast conservation surgery or mastectomy. Images will be assessed for ability to see the PEM positive lesions on the lower dose images and this will be compared to the ability to see the PEM positive lesions on the standard higher dose images. Each of three breast cancer categories will be assessed Infiltrating Ductal Carcinoma, Lobular infiltrating Carcinoma, and Ductal Carcinoma Insitu. Phase 1 will have 30 patients.

The purpose of the research in Phase 2 is to use the lowest dose identified in Phase 1 for imaging primary breast cancer patients who have been identified by breast MRI to have an unsuspected second lesion of the breast not expected from Mammography or Ultrasound that requires biopsy for diagnosis prior to the biopsy to compare the reliability of PEM and MRI for identifying breast cancer at the 2nd site. Parameters assessed will include standard statistical analysis for sensitivity, specificity, positive predictive value and negative predictive value for MRI and PEM imaging with the new lower radionuclide dose selected by Phase 1. Phase 2 will have 100 patients.