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Brief Title: Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
Official Title: Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
Study ID: NCT02777164
Brief Summary: The objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader Study on a subset of women with histology confirmed cancer and healthy women with dense breast.
Detailed Description:
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
MemorialCare Breast Center, Saddleback Memorial, Laguna Hills, California, United States
Name: David Izhaky
Affiliation: Real Imaging Ltd.
Role: STUDY_DIRECTOR