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 : February 11, 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03835897
|Contact: Woo Kyung Moon, MD PhDemail@example.com|
|Contact: Hee Jung Shin, MD PhDfirstname.lastname@example.org|
|Principal Investigator:||Woo Kyung Moon, MD PhD||Professor|