Determination of Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- To determine the sensitivity of the dual-head system relative to single-head for detection of sub 10 mm breast lesions, and to determine the number of images that need to be acquired.
研究概览
简要总结
This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.
详细描述
If you agree to take part in this study, you will be asked to remove your clothes from the waist up and put on a gown. A female technologist will give you an injection of Tc-99m sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10 minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The technologist will position your breast between two small cameras. The cameras will apply a very light compression to your breast to make sure there is no movement during the picture. We will take two pictures of each breast. Each picture takes 10 minutes. You will also be asked to fill out a short questionnaire. If you are found to have additional breast lesions, your doctor and radiologist will be notified so that additional imaging or biopsies can be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Have a lesion on Mammogram, Ultrasound or MRI that measured < 2 cm and considered suspicious or suggestive of malignancy
- •Scheduled for biopsy of lesion
- •> 18 years of age
- •Negative pregnancy test, postmenopausal, or surgically sterilized
排除标准
- •Prior needle biopsy
结局指标
主要结局
To determine the sensitivity of the dual-head system relative to single-head for detection of sub 10 mm breast lesions, and to determine the number of images that need to be acquired.
时间窗: 2 years
次要结局
未报告次要终点