NCT01806558已完成不适用
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
研究概览
简要总结
A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria:
- •Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is >0.5 cm and < 2 cm in size and has had or will have additional workup with focused ultrasound.
- •Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is > 0.5 cm and < 2 cm in size.
- •Have a positive finding on MBI that is < 2 cm in size and requires additional diagnostic workup with focused ultrasound.
排除标准
- •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 undergone bilateral mastectomy
- •Are not scheduled to undergo conventional ultrasound
研究组 & 干预措施
Women with lesion on MBI
Experimental
Women with lesion on MBI
干预措施: Molecular Breast Imaging (Procedure)
结局指标
主要结局
To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
时间窗: 1 year
Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.
次要结局
未报告次要终点
研究者
研究点 (1)
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