NCT00981812已完成不适用
Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
研究概览
简要总结
The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.
详细描述
See brief summary.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •subject is 25-100 years of age
- •subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
- •subject is able to provide informed consent
排除标准
- •subject is pregnant
- •subject is actively lactating or discontinued breastfeeding less than 2 months ago
- •subject has breast implants
- •subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study
- •subject has contraindications for core biopsy and other invasive procedures
- •subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus
- •subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months
- •subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging
结局指标
主要结局
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
时间窗: At time of biopsy
次要结局
未报告次要终点
研究者
Mary Mahoney
Professor, Director of Breast Imaging
University of Cincinnati
研究点 (2)
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