A Multicenter, Open-Label, Crossover Trial to Assess Non-Inferiority of Dual Energy Contrast-Enhanced Digital Mammography (DE-CEDM) Compared to Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) for Identifying a Change in Patient Management in Women With Newly Diagnosed Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 224
- 试验地点
- 6
- 主要终点
- Average Maximum Lesion Size by Histology Outcome
研究概览
简要总结
Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM).
详细描述
Enrolled women will undergo a bilateral Contrast-Enhanced Breast Magnetic Resonance Imaging (CE-BMRI) as per usual clinical practice within 30 days of breast cancer diagnosis. Up to 8 weeks after the CE-BMRI exam, subjects will undergo a Dual Energy Contrast Enhanced Digital Mammograph (DE-CEDM). Maximum lesion size was compared between the two imaging types. Subject data from both scans was planned to be included in a multi-reader evaluation; however, due to premature stop of the study, multi-reader data was not collected.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Woman 21 years of age or older
- •The subject is able and willing to comply with study procedures and signed and dated informed consent is obtained.
- •Newly diagnosed with Breast Cancer (DCIS or invasive) identified through core biopsy or fine-needle aspiration (FNA) within last 30 days.
- •Will have or have had a bilateral CE-BMRI performed within 30 days AFTER the new breast cancer diagnosis.
排除标准
- •Woman who has already had a lumpectomy for the index lesion.
- •Woman undergoing neoadjuvant chemotherapy treatment, hormone treatment or radiation therapy.
- •Woman who is pregnant or who believe she may be pregnant.
- •Woman who has breast implant.
- •Woman who has a contraindication to the intravenous use of iodinated or gadolinium-chelated contrast agent (e.g., allergy to either agent or severely impaired renal function).
研究组 & 干预措施
CE-BMRI
Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.
干预措施: CE-BMRI (Device)
CE-BMRI
Subject will undergo bilateral CE-BMRI as per usual clinical practice within 30 days after the new breast cancer diagnosis. Subject will then undergo bilateral DE-CEDM examination within 8 weeks after the CE-BMRI exam.
干预措施: DE-CEDM (Device)
结局指标
主要结局
Average Maximum Lesion Size by Histology Outcome
时间窗: Approximately 1 week; upon completion of histology report
Average maximum lesion size as described in histology report.
Completion of CE-BMRI and DE-CEDM
时间窗: Approximately 8 weeks
Subjects have completed both CE-BMRI and DE-CEDM scan types
Average Maximum Lesion Size by CE-BMRI Scan
时间窗: Within 1 week of CE-BMRI scan
Average maximum lesion size when scanned using CE-BMRI
Average Maximum Lesion Size by DE-CEDM
时间窗: Within 1 week of DE-CEDM scan
Average maximum lesion size when scanned using DE-CEDM
Multi-reader Evaluation of Images
时间窗: This outcome did not occur due to premature study stop.
Multi-reader evaluation of images and comparison between CE-BMRI vs. DE-CEDM to determine which technology can more precisely measure cancer size as determined by pathological examination was planned. This was not conducted due to premature stop of the study.
次要结局
未报告次要终点