Breast Cancer Screening With Diffusion-weighted MRI in Women at High Risk for Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT03835897
- Lead Sponsor
- Seoul National University Hospital
- 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.
* 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
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 890
- 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
- 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.).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity 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 Outcome Measures
Name Time Method Specificity 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) Baseline to up to 1 year Number of detected cancers (invasive and in situ cancer) /1000 examinations
Biologic characteristics of breast cancer Baseline to up to 1 year histologic type, tumor grade, and molecular subtype of breast cancers
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of