NCT02013726撤回不适用
Pilot Study: Dedicated Dual Head Molecular Breast Imaging Compared to Breast Tomosynthesis for Evaluation of Patients With Type 3 or 4 Mammographic Breast Density
Gamma Medica, Inc.0 个研究点开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Sensitivity/Cancer detection
研究概览
简要总结
Primary:
In women with heterogeneous or dense breast tissue (mammographic types 3 and 4), MBI (Molecular Breast Imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis.
Secondary:
- In women with heterogeneous or dense breast tissue, the specificity of MBI in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis.
- In women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (ROC) curve for MBI will be non-inferior or superior to breast tomosynthesis.
- Combining the use of MBI and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior ROC curve area.
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
- 是
入选标准
- •Women over 25 years of age with normal or increased risk of breast cancer.
- •Women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks).
- •No contraindications to breast MBI or breast tomosynthesis.
排除标准
- •Women under the age of
- •Women who are or may be pregnant.
- •Women who are currently lactating or have discontinued breast feeding < 2 months prior to the study.
- •Male patients are excluded as subjects.
- •Those unable or unwilling to provide informed consent.
结局指标
主要结局
Sensitivity/Cancer detection
时间窗: 12 months
Sensitivity being the number of scans read or labeled positive (by radiologist) divided by the total cancers confirmed by pathology results (i.e. biopsy).
次要结局
- Specificity(12 months)
研究者
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