DWI Breast MRI in Dense Breast: A Clinical Trial to Assess the Efficacy and Diagnostic Accuracy of Diffusion Weighted Imaging in Dense Breast Tissue
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study
研究概览
简要总结
his clinical trial aims to evaluate the efficacy and diagnostic accuracy of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. DWI is investigated as an adjunctive method to improve early tumor detection in women with dense breasts, a group at high risk for delayed diagnosis due to limited visibility in mammography.
Study Purpose:
To assess the utility of Diffusion Weighted Imaging (DWI) in improving diagnostic accuracy for patients with dense breasts.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 40-75 years.
- •Patients with dense breast tissue, classified according to BI-RADS (Breast Imaging-Reporting and Data System).
- •Patients who previously underwent breast MRI, including Diffusion Weighted Imaging (DWI).
- •Availability of histopathological confirmation for breast lesions (biopsy results).
排除标准
- •Patients with a known allergy to gadolinium-based contrast agents.
- •Pregnant or breastfeeding women at the time of imaging.
- •Presence of metallic implants or other MRI-incompatible devices.
- •Patients with incomplete imaging datasets (e.g., missing DWI sequences or non-standardized protocols).
- •Prior history of breast cancer treatment (surgery, chemotherapy, or radiotherapy) before the imaging study.
结局指标
主要结局
Accuracy of Diffusion Weighted Imaging (DWI) in Dense Breast Tissue: A Retrospective Cohort Study
时间窗: 12 months
This retrospective cohort study aims to assess the diagnostic accuracy and clinical utility of Diffusion Weighted Imaging (DWI) in breast MRI for women with dense breast tissue. By analyzing previously collected imaging data, the study evaluates the sensitivity, specificity, and predictive value of DWI in detecting malignant breast lesions. The research also examines the correlation between Apparent Diffusion Coefficient (ADC) values and histopathological tumor characteristics, comparing DWI's performance with conventional MRI and mammography/tomosynthesis.
次要结局
未报告次要终点
研究者
Graziella di Grezia
Principal Investigator
Link Campus University