JPRN-jRCTs062180005已完成未知
Diagnostic accuracy of portable breast tumor detector for breast tumor - PORBRATOR-2
Okada Morihito0 个研究点目标入组 120 人开始时间: 2018年11月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 120
研究概览
简要总结
The sensitivity of the study device to detect breast cancer was 80% and was not affected by breast cancer subtype, tumor size, or breast density. It was found to be low in specificity and the resolution of false positives was a challenge. Further improvements in the instrument and analysis algorithms are needed for clinical applications.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •1. Female older than 20 years old.
- •2. Patients with histologically confirmed breast cancer (only cohort 1).
- •3. Confirmed breast tumor by one or more arbitrary image examination; mammography, breast ultrasonography, contrast breast MRI and FDG-PET examination.
- •4. Signed informed consent.
排除标准
- •1. History of chemotherapy or radiotherapy within 6 months before registration.
- •2. Hypersensitivity to ABS plastic resin.
- •3. Having a pacemaker.
- •4. Decision of the physician.
研究者
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