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MBI and Breast Tomosynthesis Screening Accuracies in Patients With Dense Breast Tissue

Gamma Medica, Inc. · 2015
ClinicalTrials.gov · Datasets · License: Public Domain · 2015
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breast-neoplasmsna
Primary: In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis. Secondary: 1. In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis. 2. In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis. 3. Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.
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