Trial Information

Clinical Value of Pre-Surgery Positron Emission Mammography (PEM) in Patients With Newly Diagnosed Breast Cancer

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.