Digital Breast Tomosynthesis Guided Tomographic Optical Breast Imaging (TOBI)
试验速览
- 阶段
- 不适用
- 入组人数
- 375
- 试验地点
- 2
- 主要终点
- Area under the curve for distinguishing benign vs malignant lesions
研究概览
简要总结
Screening for breast cancer improves early detection of aggressive cancers and has been shown to reduce breast cancer related mortality. Currently, mammography is the most effective way of detecting early stage, non palpable breast cancers. However, mammography only reveals the breast structure, and cannot say much about the breast physiological state. We propose Tomographic Optical Breast Imaging (TOBI) as an inexpensive, patient friendly technique that is non-invasive and does not use non-ionizing radiation. TOBI uses near infrared light and by measuring how such light passes through the breast, images of blood volume and hemoglobin oxygenation can be obtained. In this study, TOBI is combined with digital breast tomosynthesis (DBT, a form of 3D mammography) and our hypothesis is that the TOBI-DBT combined images can be used to diagnose breast cancer with significantly improved sensitivity and specificity compared to DBT alone.
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
- 是
入选标准
- •Any adult female volunteers of any race or ethnic background, between the ages of 30 to 80, either
- •scheduled for a clinically indicated diagnostic mammogram or percutaneous biopsy.
- •presenting for breast cancer treatment
排除标准
- •Under 30 years old or over 80 years old
- •Is pregnant or thinks she may become pregnant.
- •Open wounds on breast
- •Breast implants
- •Any condition that impairs the ability to give informed consent
研究组 & 干预措施
TOBI + DBT
TOBI + DBT of women presenting for breast imaging.
干预措施: TOBI + DBT (Device)
结局指标
主要结局
Area under the curve for distinguishing benign vs malignant lesions
时间窗: 5 years
We will compare optical-DBT vs DBT in terms of diagnosis specificity within the diagnostic population. We will base our analysis on total hemoglobin contrast which has been shown before by our group to be significantly different between malignant and benign lesions. By setting a threshold total hemoglobin ratio and comparing with the biopsy results, we can obtain a point on the receiver operating characteristic (ROC) for the selected parameter. By sliding the threshold over all possible values, we will render the full ROC curve. The area under the curve (AUC) will be calculated to compare with that of DBT.
次要结局
未报告次要终点
研究者
Mansi A Saksena
Assistant Professor at Massachusetts General Hospital
Massachusetts General Hospital