A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 218
- 试验地点
- 4
- 主要终点
- Identification of the optical signatures in breast tissue
研究概览
简要总结
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
详细描述
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.
Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Patients undergoing a reduction mammoplasty OR
- •Patients undergoing a lumpectomy mastectomy for the treatment of an invasive or non-invasive breast malignancy
- •Age > 18
- •Clinically detectable disease either by physical examination or radiographic studies
- •Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients considered in "vulnerable" populations.
结局指标
主要结局
Identification of the optical signatures in breast tissue
时间窗: Day of procedure (less than 10 minutes)
次要结局
- Sensitivity and Specificity of the device(Day of procedure (less than 10 minutes))