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Clinical Trial Summary

A prospective observational multicenter study to compare the outcome of breast cancer surveillance using mammography, breast US, contrast-enhanced MRI, and diffusion-weighted MR imaging (DWI) as a screening tool, in the high-risk women for breast cancer. - Primary objective: To compare the sensitivity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer - Secondary objective: 1. To compare the specificity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer 2. To compare the cancer detection rate of mammography, breast US, contrast-enhanced MRI, and DWI 3. To compare the characteristics of detected cancers

Clinical Trial Description

- Mammography, breast US, contrast-enhanced MRI, and DWI will be performed on the same day or within 1 month at baseline and then after 1 year, and images will be interpreted independently according to the Breast Imaging Reporting and Data System (BI-RADS) by experienced radiologists. - Each eligible woman, who provides informed consent for this study, will undergo mammography, breast US, contrast-enhanced MRI, and DWI at a 3T MR scanner. - Contrast-enhanced breast MRI will be performed before and after a gadolinium-based contrast agent injection. - Before contrast injection, DWI with b-value of 0, 800 and 1200 s/mm2 will be performed and will transfer into the server. - A total of 890 high-risk women for breast cancer will be enrolled in this study. - The BI-RADS 3 or higher is defined as test-positive. The reference standard will be a biopsy or at least 1 year of follow-up. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03835897
Study type Observational
Source Seoul National University Hospital
Contact Woo Kyung Moon, MD PhD
Phone +82220722584
Email [email protected]
Status Recruiting
Start date April 3, 2019
Completion date December 2022

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