NCT00942396撤回3 期
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Planmed Oy4 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2008年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 250
- 试验地点
- 4
- 主要终点
- Area under ROC curve based on subjects' maximum POM scores; sensitivity based on subjects' maximum BI-RADS scores with 4 or higher as positive for cancer; and specificity based on subjects maximum BI-RADS scores with 4 or higher as positive for cancer
研究概览
简要总结
Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.
详细描述
Objectives: 1) To establish the non-inferiority of the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer; and 2) To demonstrate in a comparative side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject is 40 years of age or older
- •Subject is presenting for routine breasts cancer screening (Cohort I) OR Subject has one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography (Cohort II)
- •Subject's schedule permits the SFM and the FFDM to be performed no more than 30 days apart and with no intervention between the exams
- •Subject will provide prospective, written informed consent
- •Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam -
排除标准
- •Subject is pregnant or possibly pregnant or planning pregnancy within the next 15 months
- •Subject has undergone a breast augmentation or breast implant? Has subject had any of the following breast procedures?
- •Fine needle or cyst aspiration NOT Eligible if within past year Biopsy Not Eligible if within past year Lumpectomy (for breast cancer) Mastectomy (for breast cancer) Radiation therapy Breast reconstruction Breast reduction Not Eligible if within past year
- •Subject has had an invasive breast procedure or operation within the past year
- •Subject has significant existing breast trauma
- •Subject has a history of breast cancer treated with operation or radiation
- •Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data
结局指标
主要结局
Area under ROC curve based on subjects' maximum POM scores; sensitivity based on subjects' maximum BI-RADS scores with 4 or higher as positive for cancer; and specificity based on subjects maximum BI-RADS scores with 4 or higher as positive for cancer
时间窗: Approximately one year after completion of study.
次要结局
- area under the ROC curve based on the POM scores from the ten regions of a subject's breasts;(Approximately one year after completion of study.)
- area under the ROC curve based on the maximum POM score per subject-breast(Approximately one year after completion of study.)
- sensitivity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;(Approximately one year after completion of study.)
- specificity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;(Approximately one year after completion of study.)
- Sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 4 or higher for positive; and sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 3 or higher for positive.(Approximately one year after completion of study.)
- Feature Analysis Study; side by side assessment of SFM and FFDM images and comparison of quality features: lesion conspicuity, tissue visibility at chest wall, tissue visibility at skin line, axillary details (MLO), overall contrast, overall sharpness(Approximately one year after completion of study.)
- Adverse event assessment(Approximately 24 hours after completion of FFDM)
研究者
研究点 (4)
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