Molecular Imaging of Breast Cancer With Breast PET/CT
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device.
研究概览
简要总结
This study is a feasibility study to determine if a combined breast PET/CT scanner can image malignant functional activity while determining anatomical structure in the same clinical setting for patients with breast cancer. End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device. The secondary purpose of this study is to explore protocol parameters with a view to optimizing imaging performance whilst minimizing patient discomfort. Imaging results will be compared to histological samples to determine ground truth.
详细描述
PET is literally a molecular imaging modality. In monitoring the patient's response to a specific chemotherapeutic regime, baseline and subsequent PET/CT scans can be used to quantitatively determine the therapeutic effect of the regime, using the standard uptake value (SUV), a common metric in PET imaging. The breast PET/CT system will facilitate molecular imaging of breast cancer using a number of radiolabeled molecules, available both commercially (18-FDG) and from the research environment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Normal Adult Volunteers
- •Female, at least 18 years of age
- •Ability to lie motionless for up to 20 minutes
- •Patient Volunteers
- •Female, at least 18 years of age
- •Diagnostic findings from prior mammography highly suggestive of invasive breast carcinoma (BI-RADS category 5)
- •Not pregnant or breast-feeding
- •Ability to lie motionless for up to 20 minutes
排除标准
- •Normal Adult Volunteers
- •Inability to understand the risks and benefits of the study
- •Patient Volunteers
- •Recent breast biopsy
- •Diagnostic findings from prior mammography highly suggestive of noninvasive ductal or lobular carcinoma
- •Uncontrolled diabetes
- •Diabetic and blood sugar level > 200 mg/dL
- •Positive urine pregnancy test or currently breast-feeding
- •Inability to understand the risks and benefits of the study
结局指标
主要结局
End-points of this study are whether women will accept the imaging position and timing, and whether functional properties of breast cancer can be imaged with this device.
时间窗: 5 years
次要结局
未报告次要终点
研究者
Ramsey Badawi, Ph.D
Associate Professor
University of California, Davis