Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Accurate classifications of women with or without breast cancer
研究概览
简要总结
This pilot clinical trial studies light-scattering spectroscopy in finding disease in patients with stage II-III breast cancer. Diagnostic procedures, such as light-scattering spectroscopy, may help find and diagnose breast cancer
详细描述
PRIMARY OBJECTIVES: I. To evaluate whether light-scattering spectroscopy can reliably distinguish between two subject groups: those with clinical stage II or stage III breast cancer and those without breast cancer.
OUTLINE: Patients undergo light-scattering spectroscopy of the breast in addition to standard of care as it relates to screening for breast cancer or treatment of breast cancer.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participants who are breast cancer free (mammogram "negative" within 1 month of testing) with the absence of clinical suspicion of breast cancer on physical exam or with clinical stage II or stage III breast cancer. PLEASE NOTE: Recruitment for this study is only limited to patients who are scheduled for a mammogram at USC. There is no compensation to participants.
- •Provision of informed consent prior to any study-related procedures
排除标准
- •Females with tattoos on either or both breasts
- •Females with nipple piercings on either or both breasts
- •Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
- •Females unable to provide informed consent
- •Females s/p treatment for breast cancer
结局指标
主要结局
Accurate classifications of women with or without breast cancer
时间窗: Up to 1 year
Exact binomial probabilities will be used.
Utility of optical markers in distinguishing cancer involved breasts from normal breasts
时间窗: Up to 1 year
Multivariate analyses will be used.
次要结局
未报告次要终点