NIR (Near Infrared Spectral Tomography)Hypoxia Imaging of Breast Tumor Response to Neoadjuvant Chemotherapy in Vivo.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor.
研究概览
简要总结
The purpose of this study is to determine whether an experimental alternative imaging method, Near Infrared Spectroscopy (abbreviated as NIR), can be used with a controlled respiratory system to examine the breasts for cancer. The NIR system uses light beams to produce an image or picture of the inside of the breast. The respiratory system will help researchers get more information about the breast tissue by changing the amount of oxygen the tissue receives during NIR imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 76 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •NORMAL cohort
- •Breast size and epithelial integrity adequate to allow NIR imaging exams
- •No serious associated psychiatric illnesses
- •Female, ≥25 and <76 years old
- •Written informed consent
- •UNDER TREATMENT cohort
- •Locally advanced breast cancer, with or without metastatic disease, defined as being clinically appropriate for neoadjuvant therapy
- •Breast size and epithelial integrity adequate to allow NIR imaging exams
- •No serious associated psychiatric illnesses
- •Female, ≥25 and <76 years old
- •Written informed consent
排除标准
- •both cohorts
- •Pre-existing respiratory conditions:
- •severe chronic obstructive pulmonary disease (including chronic bronchitis and/or emphysema)
- •Other respiratory or lung conditions which would place the patient at risk
- •presence of any other significant cardiac or pulmonary symptoms, such as moderate or severe dyspnea on exertion, orthopnea, or paroxysmal nocturnal dyspnea
- •Congestive heart failure
- •Intolerance of hyperoxia or hypercarbia as delivered by the RespirAct breathing circuit
结局指标
主要结局
Quantify tumor oxygenation response in patients imaged.Determine capability of imaging dynamic to capture oxygenation changes within the tumor.
时间窗: 18 weeks approximately
Analyze captured data from use of dynamic NIR topographic oximetry (in a cohort of women receiving conventional anthracycline/taxane based adjuvant chemotherapy).Quantify pathological and clinical outcomes.
次要结局
未报告次要终点