Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Sensitivity of Light-CT
研究概览
简要总结
Intraoperative pathological diagnosis such as frozen section and imprint cytology is not routinely recommended in clinical practice because of time and accuracy concerns. Full-field optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the morphological structure and pathological changes in minutes without conventional tissue preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability information of cells/tissue, which could be more important in cancer diagnosis. This study was to evaluate the feasibility and diagnostic value of FF-OCT and DCI in breast lesions and lymph node specimens during breast cancer surgery. We evaluated normal breast tissue, benign breast lesions, breast cancer and axillary lymph node specimens resected from patients undergoing breast surgery.
详细描述
Light-CT, a special-designed pathology-approximation system which is based on the lighting feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue in fresh specimens. Morphological structure and pathological changes could be captured in minutes, which implies a possible application in intraoperative diagnosis. In this study, fresh breast tissue, fat, benign breast lesions, breast cancer and axillary lymph node specimens are collected to assess the usefulness of Light-CT. During the in vitro examination, both FF-OCT and DCI images are obtained and stored. Imaging analysis would be performed in traditional imaging analysis like manner and an artificial intelligence aided approach as well.
In this study, breast and lymph node specimens would be collected and imaged both through light imaging and conventional pathological analysis.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients planning to undergoing breast surgery/surgical lymph node staging.
- •Specimen could be obtained.
排除标准
- •Prior open biopsy
结局指标
主要结局
Sensitivity of Light-CT
时间窗: One week after the release of the pathological reports.
The true positive rate measures the proportion of positives that are correctly identified by ultrasound
次要结局
- The lighting feature of different tissue(Through study completion, an average of 1 year)
- Examination time(Through study completion, an average of 1 year)
- Specificity of Light-CT(One week after the release of the pathological reports.)