Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational Device
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Number of subjects (cases) with lesions
研究概览
简要总结
This is a prospective, multi-center image case collection study to acquire de-identified contrast-enhanced breast images on a mammography device to support continuing software technology development. Eligible subjects include women at least 35 years old with a suspicious finding or breast abnormality on a screening or diagnostic mammogram who are indicated for a diagnostic exam or a biopsy procedure.
详细描述
Contrast-Enhanced Mammography (CEM) is intended to be an extension for diagnostic mammography. It is a technique in which digital 2D mammography is supplemented with the use of intravenous iodinated contrast administration to facilitate cancer detection. The imaging acquired under a contrast agent has preferential uptake in regions of increased vascularity providing complement information for diagnosis. The CEM software application that will be tested is similar to the marketed software I-View™ 2.0 and is intended for use as an adjunct following mammography and/or ultrasound exams as a diagnostic work-up to localize and further characterize a known or suspected lesion.
Thus, to assess the clinical efficacy of the Hologic CEM software I-View in a new mammography device, Sponsor is conducting a prospective case collection study to support the verification and validation of image quality assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female of any race and ethnicity.
- •Subject is at least 35 years old
- •Subject has a suspicious finding or breast abnormality on a screening or diagnostic mammogram and is indicated for a diagnostic exam or a biopsy procedure.
- •Subject is able to read, understand, and sign the study-specific informed consent form (ICF) after the nature of the study has been fully explained to them.
排除标准
- •Subject is unable or unwilling to undergo informed consent or subject who requires a Legally Authorized Representative (LAR) for Informed Consent.
- •Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view in the breast of interest.
- •Subject has had an interventional procedure in the same breast as the suspicious finding within the last six (6) months
- •Subject is pregnant or presumed to be pregnant.
- •Subject is breastfeeding.
- •Subject is actively being treated for cancer of any type with chemotherapy
- •Subject is suspected to be at risk of complications from the iodinated contrast agent. These include contra-indications of standard iodinated contrast agents, such as the subject having renal insufficiency) and the subject being on dialysis.
- •Subject has had a prior reaction to iodinated contrast; thus, a known allergy to iodinated contrast.
- •Subject has had a prior reaction to gadolinium contrast agents; thus, a known allergy to gadolinium contrast.
- •Subject who, based on the physician's judgment, may be at increased risk for complications associated with renal function, anticoagulant therapy, or bleeding disorders.
研究组 & 干预措施
CEM Investigational Exam
干预措施: CEM Software in New Mammography Device (Device)
结局指标
主要结局
Number of subjects (cases) with lesions
时间窗: 18 months
Number of subjects with contrast-enhanced breast images containing lesions as assessed by radiologists' image quality review
次要结局
未报告次要终点