Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
研究概览
简要总结
The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI) acquired as a part of a standard clinical workup.
详细描述
This is a pilot study of CE-DBT scans to evaluate its utility relative to breast CE-MRI. Twenty women who have planned or received conventional breast MRI imaging at UNC Hospitals will be recruited for the study. Participants will be scanned with the DBT system after the administration of iodinated contrast agent. Images will be acquired prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at least 18 years old
- •Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan
- •Suspected breast lesion based on prior imaging (BIRADS 4 or greater)
- •Able to provide written informed consent
排除标准
- •Severe untreatable claustrophobia
- •Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants)
- •Known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids)
- •Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis
- •Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)
研究组 & 干预措施
Contrast-enhanced digital breast tomosynthesis (CE-DBT)
Participants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL.
干预措施: Iohexol 350 Mg/mL Injectable Solution (Drug)
结局指标
主要结局
Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
时间窗: Calculated once all imaging is complete [Anticipated 1.5 years]
To compare (using a reader study) the reader confidence in identifying lesions on CE-DBT to the reader confidence in identifying lesions on contrast enhanced dynamic breast MRI.
次要结局
- Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)(Calculated once all imaging is complete [Anticipated 1.5 years])
- Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)(Calculated once all imaging is complete [Anticipated 1.5 years])
- Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)(Calculated once all imaging is complete [Anticipated 1.5 years])
- Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)(Calculated once all imaging is complete [Anticipated 1.5 years])
- Positivity predictive value of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)(Calculated once all imaging is complete [Anticipated 1.5 years])
- Receiver Operating Characteristic (ROC) curves of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)(Calculated once all imaging is complete [Anticipated 1.5 years])