Improving Characterization of Calcifications With Contrast-Enhanced Mammography
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Evaluate risk characterization of screen-detected calcifications by CEM
研究概览
简要总结
The purpose of this study protocol is to assess whether contrast-enhanced mammography (CEM) will increase the accuracy of characterization of microcalcifications detected on screening mammography prior to biopsy as either benign, high risk, or malignant.
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
- •Women with calcifications detected on screening mammogram for which biopsy is recommended following characterization on diagnostic mammography.
- •At least 30 years of age.
- •Able to understand and willing to sign an IRB-approved written informed consent document
- •GFR ≥ 30 mL/min/1.73 m2
排除标准
- •Prior history of allergy or hypersensitivity reaction to iodinated contrast
- •History of chronic renal disease (including dialysis, kidney transplant, single kidney, renal cancer, or renal surgery)
- •Patients with known thyroid disorders, pheochromocytoma or sickle cell anemia
研究组 & 干预措施
Contrast-enhanced mammography (CME)
-Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM.
干预措施: Contrast-enhanced mammography (Device)
Contrast-enhanced mammography (CME)
-Patients who meet eligibility criteria and consent to participate in this study will complete a CEM examination prior to or on the day that biopsy is scheduled. CEM must occur no later than 60 days after the diagnostic mammogram. The standard of care biopsy must occur no later than 30 days after CEM.
干预措施: Biopsy (Procedure)
结局指标
主要结局
Evaluate risk characterization of screen-detected calcifications by CEM
时间窗: Up to 30 days after the CEM
-The proportion of women with abnormal enhancement (yes/no) will be compared to the pathology results from the core needle biopsy (benign versus high risk/malignant)
次要结局
- Rate of detection of additional sites of disease in the same or contralateral breast on CEM(At the time of the CEM (day 1))
- Ability of CEM to determine whether accuracy for cancer detection varies as a function of breast density(At the time of the CEM (day 1))
- Ability of whether CEM accuracy for cancer detection varies as a function of the morphology of calcifications as depicted on screening and diagnostic mammography(At the time of the CEM (day 1))