NCT01713049Unknown不适用
Use of 18F-FLT Positron Emission Tomography to Evaluate the Suspicious Findings on Mammography and Breast Ultrasound: A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard.
研究概览
简要总结
The purpose: To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound.
详细描述
- To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard, and to determine whether 18F-FLT PET can increase the specificity in breast lesion diagnosis and thus reduce the unnecessary biopsy.
- To evaluate whether 18F-FLT PET is a cost-effective imaging modality for breast cancer diagnosis.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 20 to 80 years
- •women who have localized findings on mammography and / or ultrasound and will receive biopsy.
- •The lesions on the conventional imaging measure >=1cm
- •WBC count >=3000/L, or platelet>=75,000/L
- •Liver function, AST or ALT < 78 U/L
- •Renal function, Creatinine < 2.0 mg/dl.The laboratory examinations should be performed within 4months before our study.
排除标准
- •Pregnant women or who are planning to be pregnant.
- •Known cancers in other organs.
- •Women who are not able to cooperate with the PET/CT examination.
研究组 & 干预措施
18F-FLT
Other
18F-FLT PET for Suspicious Findings on Mammography and Breast Ultrasound.
干预措施: 18F-FLT (Drug)
结局指标
主要结局
To investigate the diagnostic accuracy of 18F-FLT PET for the suspicious lesions on mammograms and ultrasound, using the pathologic result of biopsy as gold standard.
时间窗: The biopsy procedures will be scheduled as soon as possible and should be finished within 2 months after 18F-FLT PET.
次要结局
未报告次要终点
研究者
National Taiwan University Hospital
National Taiwan University Hospital
National Taiwan University Hospital
研究点 (1)
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