NCT01542814已完成不适用
Acquisition of Mammography Images for Clinical Evaluation of FUJIFILM 3Dimensional Mammography
Fujifilm Medical Systems USA, Inc.3 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2012年2月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Acquire screening cases with and without breast cancer.
研究概览
简要总结
This image-acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. The acquired data will be used to support FUJIFILM protocol FMSU2011-003B (Clinical Evaluation of FUJIFILM 3Dimensional Digital Mammography) and future regulatory submissions.
详细描述
This is an image acquisition reader study to observe differences between 3D FujiFilm Mammography and 2D approved Mammography
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Any ethnic or racial origin.
- •Must come through the study via the screening or diagnostic pathway described above.
- •Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol.
- •Meet none of the exclusion criteria.
排除标准
- •• Presence of a breast implant.
- •Women with only a single breast; for example, post mastectomy patients.
- •Is pregnant or believes she may be pregnant.
- •A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
- •A woman who has significant existing breast trauma.
- •Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate mammography examinations.
- •A woman who has had a mammogram performed for the purpose of therapy portal planning.
- •Inadequate technical quality mammography images, such as insufficient anatomical coverage or significant motion artifacts.
- •Cannot, for any known reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution.
- •Is an inmate (see US Code of Federal Regulations 45CFR46.306).
结局指标
主要结局
Acquire screening cases with and without breast cancer.
时间窗: 18-months
次要结局
未报告次要终点
研究者
研究点 (3)
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