NCT03835897Unknown不适用
Breast Cancer Screening With Mammography, Ultrasound, Contrast-enhanced MRI, and Diffusion-weighted MRI in Women at High Risk for Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 890
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
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:
- 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
详细描述
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.).
结局指标
主要结局
Sensitivity
时间窗: 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
次要结局
- 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)
研究者
Woo Kyung Moon
Professor
Seoul National University Hospital
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Assessing Breast Density's Value in Imaging - A Comparative Effectiveness StudyBreast CancerNCT02980848University of California, Davis1,341,172
Unknown
不适用
A Comparative Study of Mammography and Ultrasound for Breast Cancer Screening and Early DiagnosisBreast Cancer DiagnosisBreast Cancer ScreeningNCT04429269Peking Union Medical College Hospital6,000
终止
不适用
Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-upBreast CancerNCT01723124Mayo Clinic228
Unknown
不适用
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation TestingBRCA1 MutationBRCA2 MutationRecurrent Breast CancerMetachronous NeoplasmBreast CancerNCT03475979Seoul National University Hospital1,564
Unknown
不适用
Multi-center Study of Deep Learning AI in Breast MassBreast NeoplasmsNCT05443672Cancer Institute and Hospital, Chinese Academy of Medical Sciences1,122