Breast Cancer
Conditions
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.
Interventions
None listed
Sponsors
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Women aged between 30 years and 75 years at the time of enrollment 2. 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
1. Women with symptoms or signs of breast cancer or recurrence 2. Women with bilateral mastectomy 3. Pregnant or lactating women 4. Women who undergo chemotherapy due to malignancy in other organs 5. 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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactWoo Kyung Moon, MD PhD
Backup ContactHee Jung Shin, MD PhD
Outcome results
None listed