NCT01315106终止不适用
High Resolution 3D Diffusion-weighted Breast MRI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Lesion detection rate of the new MRI method
研究概览
简要总结
The purpose of this study is to determine how well a new MRI technique called "High resolution 3D diffusion-weighted breast MRI" detects breast cancer.
详细描述
The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI method for breast cancer detection. The study design is a single arm observational study. The new technique will be added on to the standard sequences that a women undergoes during a breast MRI. The resulting images will be compared with her standard breast MRI images, and with results of subsequent pathology.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer.
排除标准
- •Patient undergoing chemotherapy. These patients are excluded because chemotherapy changes the biology of breast cancers. Since the ultimate objective of the research is to develop a new imaging method for breast MRI screening (detection of previously unknown tumors), results in treated tumors would not be relevant. Including treated tumors could yield a misleading assessment of the performance of the new method since treated tumors have different imaging characteristics than de novo tumors.
- •Patient scheduled for pre-operative chemotherapy. These patients are excluded if they are going to be treated only on the basis of fine needle aspiration. The project seeks to correlate all tumors detected with standard histopathology of their untreated neoplasm. This exclusion criteria will be very unusual because most patients planning neoadjuvant chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate histopathologic proof necessary for enrollment.
结局指标
主要结局
Lesion detection rate of the new MRI method
时间窗: 4 weeks
Sensitivity of the new MRI method
时间窗: 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Apparent Diffusion Coefficient as a Prognostic Biomarker in Cervical CancerCancerNCT01937533Institute of Cancer Research, United Kingdom236
已完成
不适用
Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot StudyBreast CancerNCT01938157University of North Carolina, Chapel Hill55
已完成
不适用
High Resolution MRI Study for Prostate CancerProstate CancerNCT03292874Cedars-Sinai Medical Center64
已完成
不适用
Application of High Resolution Diffusion-weighted MR Imaging Pulse Sequence in Head and Neck, and Prostate CancersHead and Neck CancerProstate CancerNCT01535898Memorial Sloan Kettering Cancer Center10
已完成
不适用
Magnetic Resonance Imaging of Gynecologic Malignancies Involving the VaginaVaginal CancerNCT01703195M.D. Anderson Cancer Center12