Impact of Dedicated Breast PET Imaging vs. Conventional Two-View Digital Mammography on Recall Rates and Cancer Detection as a Screening Examination in Underserved Women
- To install the breast PET system and to test and ensure its compliance with all
regulatory agencies including the ACR and FDA.
- To measure and compare the number of call-backs for positron emission mammography (PEM)
imaging and conventional mammography, and to calculate the number of true positive and
false positive exams for mammograms and PEM imagining using pathologic results and
yearly follow-up mammogram results (cancer detection rate) in women with dense breast
tissue or at high risk for breast cancer.
- To measure and compare patient satisfaction for both conventional mammography and PEM
in terms of comfort and pain.
- To measure and compare the cost effectiveness with conventional mammography vs PEM by
examining cost, examination time, and radiologist reading time.
OUTLINE: Patients undergo a conventional two-view mammogram and positron emission
mammography (PEM). Immediately following treatment, patients complete a questionnaire on
their satisfaction with the standard mammogram and the PEM.
After completion of study treatment, patients are followed annually.
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Frequency of recall from screening to evaluate a focal image abnormality on each study alone and in combination based on the Breast Imaging Assessment Reporting and Data System (BI-RADS) assessment
Gustavo Mercier, MD, PhD
Boston Medical Center
United States: Food and Drug Administration
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