NCT04491864终止不适用
DWIBS-MRI: An Adjunct to the Traditional Diagnostic Breast Imaging Evaluation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- MRI DWIBS Accuracy
研究概览
简要总结
1.1. Primary Objectives
- To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
- We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis.
- Once we validate the use of DWIBS-MRI ADC values to determine malignancy, can we establish an ADC threshold value to decrease the number of false positive biopsies that are performed while still maintaining a zero false negative rate?
- This study will also assess the correlation between ADC values and the Ki-67 proliferative index of malignant lesions.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •A patient will be eligible for inclusion in this study if she meets all of the following criteria:
- •>30 years of age
- •Genetic Female
- •Suspected diagnosis of BIRADS 4 or BIRADS 5 masses and/or asymmetries greater than 1 centimeter based on standard 2D/3D mammogram and ultrasound imaging.
排除标准
- •A patient is ineligible for inclusion in this study if she meets any of the following criteria:
- •Prior biopsy of suspicious lesion
- •Breast implants
- •Prior history of breast cancer
- •Patient has a pacemaker
- •Contraindications to use of MRI imaging (metal implants, etc.)
- •Woman pregnant or lactating
- •Calcifications as only findings present for a suspicious lesion
结局指标
主要结局
MRI DWIBS Accuracy
时间窗: 1 month
• To determine if MRI DWIBS can accurately identify suspicious lesions previously categorized on mammography and sonography as potentially malignant.
Validate DWIBS-MRI
时间窗: 1 month
• We will also validate whether DWIBS-MRI ADC values can be used to accurately differentiate benign from malignant lesions. Additionally, because it is not known whether tumor type or growth rate (Ki67 values) will affect our results, we will include these parameters in our analysis.
次要结局
未报告次要终点
研究者
Sean Raj
Medical Doctor
Baylor Research Institute
研究点 (1)
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