Imaging Quality and Potential Clinical Relevance of Phase Contrast
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM.
研究概览
简要总结
Conventional mammography, breast sonography and breast MRI have specific weaknesses. In particular, mammography has a low sensitivity for the detection of mammary carcinoma in patients with a dense breast. Phase contrast mammography could help to overcome some of these limitations. Observational study.
详细描述
Category C2 Medicine product without CE label.
Objective(s):
Phase 0: Imaging of mastectomy and breast biopsy samples to validate the image quality and radiation dose. Phase 1: Determination of accurate radiation dose in vivo; dose exposure should remain within the range specified in the investigational brochure. Evaluation of cohort size for phase 2. Phase 2: Assessment of the diagnostic performance of phase contrast mammography compared to conventional digital mammography.
Ouctomes: Sensitivity and specificity of phase contrast mammography compared to conventional digital mammography.
Measurements and procedures:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria -Phase 0:
- •>18 years
- •Mastectomy, tumorectomy or biopsy planned
- •Informed consent of the patient
- •Inclusion criteria -Phase 1:
- •>18 years
- •BI-RADS 5 (highly suggestive of malignancy at ultrasound or mammography) or 6 (known biopsy proven malignancy);
- •Scheduled for mastectomy or breast conserving surgery with radiotherapy.
- •Informed consent of the patient
- •Inclusion criteria - Phase 2:
- •>40 years
- •undergoing mammography for screening or diagnostic purpose.
- •Informed consent of the patient
排除标准
- •Exclusion criteria for all three Phases:
- •Breast implants. The women will be asked, if they have a breast-implant.
- •Inability to understand the study procedure due to cognitive or linguistic deficits.
- •Exclusion criteria for patients, participating in Phase 1 and Phase 2:
- •Pregnancy
- •Breast-feeding.
- •Re-staging after neoadjuvant chemotherapy. Patients who participated in prior research projects with ionizing radiation in the past 12 months
结局指标
主要结局
Sensitivity and specificity of PCM compared to FFDM represent the primary outcome since the limited sensitivity of mammography, in particular in patients with dense breasts, represents the major limitation of the currently applied FFDM.
时间窗: 30 month
The standard reference will be the histologic specimen after biopsy
次要结局
- Lesion extent will be estimated using both PCM and FFDM. Pathological measurements obtained from the surgical specimen will be used as standard of reference.(30 month)