Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer

Breast Cancer Clinical Trial

Official title: Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT03835897
• Study type: Observational
• Source: Seoul National University Hospital
• Contact: Woo Kyung Moon, MD PhD
• Phone: +82220722584
• Email: moonwk@snu.ac.kr
• Status: Recruiting
• Start date: April 3, 2019
• Completion date: December 2022