Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03835897|
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : March 4, 2019
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
- To compare the specificity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer
- To compare the cancer detection rate of mammography, breast US, contrast-enhanced MRI, and DWI
- To compare the characteristics of detected cancers
|Condition or disease|
- 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 and 1000 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 Type :||Observational|
|Estimated Enrollment :||890 participants|
|Official Title:||Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer|
|Estimated Study Start Date :||March 2019|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2022|
- Sensitivity [ Time Frame: Baseline to up to 1 year ]Number of positive examinations with a tissue diagnosis of cancer within 1 year / All cancers present in the population examined in the same time period
- Specificity [ Time Frame: Baseline to up to 1 year ]Number of negative examinations without tissue diagnosis of cancer within 1 year / All examinations without tissue diagnosis of cancer within the same period
- Cancer detection rate (CDR) [ Time Frame: Baseline to up to 1 year ]Number of detected cancers (invasive and in situ cancer) /1000 examinations
- Biologic characteristics of breast cancer [ Time Frame: Baseline to up to 1 year ]histologic type, tumor grade, and molecular subtype of breast cancers
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835897
|Contact: Woo Kyung Moon, MD PhDfirstname.lastname@example.org|
|Contact: Hee Jung Shin, MD PhDemail@example.com|
|Principal Investigator:||Woo Kyung Moon, MD PhD||Professor|