Contrast Enhanced Ultrasound (CEUS) With US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- CEUS true positive diagnosis
研究概览
简要总结
Subjects with suspicious breast lesion (BIRADS category 4/5) who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with Contrast Enhanced Dual Energy Mammography (CEDM), Contrast Enhanced Breast MR (CEMR) and Contrast Enhanced Ultrasound (CEUS).
详细描述
The co-primary endpoints are to estimate the sensitivity and specificity of CEUS relative to pathology determined diagnosis.
- Positive predictive value of CEDM in detecting lesions seen on MR
- Estimate the negative predictive value (TN/(TN+FN)) of CEUS as an adjunct.
- Compare the frequency of recommendation of biopsy of MG±US vs MG±US plus CEUS as an adjunct based on BIRADS scores.
- Comparison of background enhancement seen on CEUS with that seen on CEDM and CEMR.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Patients, greater than 30 years of age
- •In good general health as evidenced by medical history
- •BIRADS 4 or 5 suspicious breast lesions who are scheduled for breast biopsy.
排除标准
- •Patients who are less than 30 years of age
- •Have known or suspected cardiac shunts
- •Have history of hypersensitive allergic reactions to any imaging contrast agents
- •Pregnant (a urine pregnancy test will be given at no cost to the patient)
- •Are nursing babies
- •Poor renal function
- •Are unwilling or unable (such as having a pacemaker) to undergo a CEMR
研究组 & 干预措施
patients over age 30 with suspicious BIRADS 4/5 Lesions
Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
干预措施: Contrast Enhanced imaging (Diagnostic Test)
patients over age 30 with suspicious BIRADS 4/5 Lesions
Patients who are scheduled to undergo biopsy will be recruited to undergo imaging evaluation with CEDM, CEMR and CEUS.
干预措施: Lumason (Drug)
结局指标
主要结局
CEUS true positive diagnosis
时间窗: 1 year
The number of CEUS true positive diagnosis defined as suspicious enhancement/ mass corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
CEUS true negative diagnosis
时间窗: 1 year
The number of CEUS true negative diagnosis defined as no enhancement corresponding to area of malignant pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
CEUS false negative diagnosis
时间窗: 1 year
The number of CEUS false negative diagnosis defined as no enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram.
CEUS false positive diagnosis
时间窗: 1 year
The number of CEUS false positive diagnosis defined as suspicious enhancement corresponding to area of benign pathology at the time of biopsy based on lesion biopsy recommendation from diagnostic mammogram
次要结局
未报告次要终点
研究者
Katrina N. Glazebrook, M.B., Ch.B.
Principal Investigator
Mayo Clinic