Spots Global Cancer Trial Database for Comparison of Three Methods for Early Detection of Breast Cancer

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Trial Identification

Brief Title: Comparison of Three Methods for Early Detection of Breast Cancer

Official Title: Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer

Study ID: NCT03954015

Conditions

Proliferative Breast Disease

Interventions

Contrast Enhanced imaging

Lumason

Study Description

Brief Summary: Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).

Detailed Description: The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis. 1. Positive predictive value of CEDM in detecting lesions seen on MR 2. Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct. 3. Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores. 4. Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.