Breast Neoplasms Clinical Trial
Official title:
Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 12, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Patients planning to undergoing breast surgery/surgical lymph node staging. - Specimen could be obtained. Exclusion Criteria: - Prior open biopsy |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chaoyang Hospital | Beijing | |
China | Breast Center, Peking University People's Hospital | Beijing | Beijing |
China | Xuanwu Hospital of Capital Medical University | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Sensitivity of Light-CT | The true positive rate measures the proportion of positives that are correctly identified by ultrasound | One week after the release of the pathological reports. | |
Secondary | The lighting feature of different tissue | By the comparison analysis of FF-OCT and DCI images and corresponding pathological images, lighting feature would be extracted. | Through study completion, an average of 1 year | |
Secondary | Specificity of Light-CT | The true negative rate measures the proportion of positives that are correctly identified by Light-CT. | One week after the release of the pathological reports. | |
Secondary | Examination time | The time from the specimen preparation to the completion of the examination. | Through study completion, an average of 1 year |
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