Improving PPV3 Using Contrast Enhanced Mammography (CEM) in Diagnostic Assessment by Reducing Benign Tissue Diagnosis (FP3) - A Single-Arm Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Specificity of US to classify a lesion as benign, probably benign, or suspicious
研究概览
简要总结
This pilot trial studies how well contrast enhanced mammography works in diagnosing patients with suspicious breast findings. Diagnostic procedures, such as contrast enhanced mammography, may help to reclassify findings seen on diagnostic mammography and ultrasound as benign or likely benign with what would otherwise require biopsy for confirmation.
详细描述
PRIMARY OBJECTIVES:
I. To obtain preliminary data to support the hypothesis that contrast enhanced mammography (CEM) can reduce benign tissue diagnosis (FP3) and therefore improve positive predictive value 3 (PPV3).
SECONDARY OBJECTIVES:
I. Identify specific CEM characteristics that accurately classify a finding as benign, high-risk or malignant.
II. Assess the positive and negative predictive values for each digital breast tomosynthesis (DBT), breast ultrasound and CEM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with digital breast tomosynthesis and/or ultrasound assessments of Breast Imaging Reporting and Data System (BI-RADS) 4 and 5 lesions with recommendation of needle biopsy for tissue diagnosis.
- •Abnormal findings include masses, focal, global or developing asymmetries, architecture distortions, or > 1 cm of suspicious calcifications with or without associated ultrasound abnormal findings.
- •Scheduled for imaging guided percutaneous needle biopsy.
- •Provide signed and dated informed consent form.
- •If patient is of childbearing potential, a negative pregnancy test, urine or blood, within 14 days prior to the scan.
排除标准
- •< 1 cm span of calcifications without an ultrasound correlate.
- •Pregnant patients.
- •Patients with known allergy to iodinated contrast material.
- •If patient answers YES to any of the below questions they need glomerular filtration rate (gFR) prior to contrast administration regardless of their age:
- •Have you ever been told you have renal problems?
- •Have you ever been told you have protein in your urine?
- •Do you have high blood pressure?
- •Do you have diabetes?
- •Do you have gout?
- •Have you ever had kidney surgery?
结局指标
主要结局
Specificity of US to classify a lesion as benign, probably benign, or suspicious
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False negative rate of US
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Sensitivity of MM to classify a lesion as benign, probably benign, or suspicious
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Sensitivity of contrast enhanced mammography (CEM) to classify a lesion as benign, probably benign, or suspicious
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (mammogram+ultrasound \[MM+US\] and CEM) will be calculated and compared to a final tissue diagnosis independently.
Specificity of MM to classify a lesion as benign, probably benign, or suspicious
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False positive rate of MM
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False negative rate of CEM
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False negative rate of MM
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Sensitivity of US to classify a lesion as benign, probably benign, or suspicious
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
Specificity of CEM to classify a lesion as benign, probably benign, or suspicious
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False positive rate of CEM
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
False positive rate of US
时间窗: Up to 1 year
The total number of suspicious and benign lesions on each modality (MM+US and CEM) will be calculated and compared to a final tissue diagnosis independently.
次要结局
- Negative predictive value of MM(Up to 1 year)
- Negative predictive value of US(Up to 1 year)
- Positive predictive value of CEM(Up to 1 year)
- Positive predictive value of US(Up to 1 year)
- Positive predictive value of MM(Up to 1 year)
- Negative predictive value of CEM(Up to 1 year)