Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Seoul National University Hospital
- Enrollment
- 890
- Locations
- 1
- Primary Endpoint
- Sensitivity
- Last Updated
- 5 years ago
Overview
Brief 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.
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Primary objective: To compare the sensitivity of mammography, breast US, contrast-enhanced MRI, and DWI for the detection of breast cancer
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Secondary objective:
- 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
Detailed 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.
Investigators
Woo Kyung Moon
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Women aged between 30 years and 75 years at the time of enrollment
- •Breast cancer high-risk women who meet one or more of the following criteria: 1) BRCA mutation carrier or untested first-degree relative of BRCA mutation carrier 2) Family history of breast cancer in first- or second-degree relatives and lifetime risk \>20% calculated by the Tyrer-Cuzick model 3) Family history of breast cancer in first- or second-degree relatives and personal history of breast cancer 4) Lobular carcinoma in situ, atypical ductal hyperplasia, or atypical lobular hyperplasia on previous biopsy or surgery and lifetime risk \>20% calculated by the Tyrer-Cuzick model 5) Thoracic radiation therapy between the ages of 10 and 30
Exclusion Criteria
- •Women with symptoms or signs of breast cancer or recurrence
- •Women with bilateral mastectomy
- •Pregnant or lactating women
- •Women who undergo chemotherapy due to malignancy in other organs
- •In cases of contraindications to MRI using contrast media (claustrophobia, renal insufficiency GFR\<30mL/min/1.73m2, metallic foreign body such as pacemaker or clips, history of severe side effects due to MR contrast agent, etc.).
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Specificity(Baseline to up to 1 year)
- Cancer detection rate (CDR)(Baseline to up to 1 year)
- Biologic characteristics of breast cancer(Baseline to up to 1 year)