Ultrasound and Near Infrared Imaging for Predicting and Monitoring Neoadjuvant Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Pathologic Response Based on Miller-Payne Grading System
研究概览
简要总结
To determine the accuracy of NIR/US assessment of tumor vasculature and oxygen changes in predicting and monitoring early neoadjuvant treatment response compared to pathological response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled to receive neoadjuvant chemotherapy for the treatment of newly diagnosed, locally advanced breast cancer or scheduled to receive neoadjuvant endocrine therapy with the eventual goal of surgery of newly diagnosed clinical stage II-III ER+ HER2- breast cancer (for the endocrine therapy cohort)
- •At least 18 years of age
- •Able to understand and willing to sign an IRB-approved written informed consent document
排除标准
- •Pregnant and/or breastfeeding
- •Prior history of breast cancer
- •Prior history of chest wall radiation
- •Prior history of breast reconstruction, reduction, or augmentation
结局指标
主要结局
Pathologic Response Based on Miller-Payne Grading System
时间窗: Up to 6 months
In the Miller-Payne system, the pathologic response is divided into 5 grades based on comparison of tumor cellularity between pre-neoadjuvant core biopsy and definitive surgical specimen as: * grade 1: no change or some alteration to individual malignant cells but no reduction in overall cellularity (pNR) * grade 2: a minor loss of tumor cells but overall cellularity still high; up to 30% (pPR) * grade 3: between an estimated 30% and 90% reduction in tumor cells (pPR) * grade 4: a marked disappearance of tumor cells such that only small clusters or widely dispersed individual cells remain (almost pCR); more than 90% loss of tumor cells * grade 5: no malignant cells identifiable in sections from the site of the tumor; only vascular fibroelastonic stroma remains often containing macrophages (pCR) (however, ductal carcinoma in situ (DCIS) may be present)
次要结局
未报告次要终点