An observational study in Breast Neoplasms, sponsored by Peking University People's Hospital. Status unknown at 3 sites in China. Open to female participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2021-12-21.
Sponsored by Peking University People's Hospital · Observational
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 150 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Patients planning to undergoing breast surgery and breast cancer patient planning to undergoing surgical lymph node staging are eligible for this study.
Exclusion Criteria:
All specimens are detected using Light-CT
Diagnostic Test: Light-CT
Fresh specimen is trimmed into a block with a size not larger than 2.5 cm (Typically not larger than 1.5 cm). Prepared specimen is submitted to Light-CT tests. FF-OCT images are obtained to depict the structure information and DCI images are generated to collect the dynamic information of the cell and tissue. After the imaging detection, specimens are submitted for routine pathological diagnosis to obtain corresponding pathological images.
Sensitivity of Light-CT
The true positive rate measures the proportion of positives that are correctly identified by ultrasound
Time frame: One week after the release of the pathological reports.
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.
Time frame: Through study completion, an average of 1 year
Specificity of Light-CT
The true negative rate measures the proportion of positives that are correctly identified by Light-CT.
Time frame: One week after the release of the pathological reports.
Examination time
The time from the specimen preparation to the completion of the examination.
Time frame: Through study completion, an average of 1 year
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital