NCT01723124终止不适用
Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Molecular Breast Imaging (MBI) scan
研究概览
简要总结
The purpose of this research is to evaluate whether repeating a screening Molecular Breast Imaging (MBI) study two years after an initial screening MBI study further improves breast cancer detection in women with dense breast tissue.
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 (Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •- Past prior screening mammogram within the previous 11-24 months interpreted as heterogeneously dense or extremely dense and negative or benign [Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2]
排除标准
- •Subjects will be excluded if they:
- •Are unable to understand and sign the consent form
- •Are pregnant or lactating
- •Are physically unable to sit upright and still for 40 minutes
- •Have self-reported signs or symptoms that may suggest breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
- •Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year prior to the study
- •Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase inhibitor for adjuvant therapy or chemoprevention
- •Have undergone bilateral mastectomy
- •Have had a prior MBI within 20 months of scheduled study MBI.
研究组 & 干预措施
Molecular Breast Imaging
Experimental
Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.
干预措施: Molecular Breast Imaging (Procedure)
结局指标
主要结局
Molecular Breast Imaging (MBI) scan
时间窗: Performed at Year 0 of study
The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.
次要结局
- Molecular Breast Imaging (MBI) scan(Performed at Year 2 of study)
研究者
研究点 (1)
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