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The goal of this clinical trial is to assess whether cell microscopic imaging can accurately determine the tumor-free status of surgical margins in breast cancer patients undergoing breast-conserving surgery. This study involves female patients aged 18-70 years with breast cancer who are candidates for breast-conserving surgery. The main question it aims to answer is:
- Can cell microscopic imaging provide accurate intraoperative assessment of surgical margins compared to standard frozen pathology?
Researchers will compare the results of cell microscopic imaging to those of standard frozen pathology and paraffin pathology to see if the new imaging technology can effectively and quickly determine whether surgical margins are free of cancer cells.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ES group | Experimental | Use of EndoScellâ„¢ intraoperative handheld microscope |
|
| FS group | No Intervention | without the use of EndoScellâ„¢ intraoperative handheld microscope |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoScellâ„¢ intraoperative handheld microscope | Device | The research instrument used is the EndoScellâ„¢ intraoperative handheld microscope, which employs the principle of epifluorescence. It is a miniaturized microscope that reduces the size of a traditional large optical microscope by approximately a thousand times. It is the world's first handheld micrometer-level intraoperative real-time cell imaging probe microscope. This microscope is equipped with high-definition, real-time, anti-shake, and full-coverage scanning features. It can rapidly investigate the structure and cell morphology of tissues in real-time. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | Compare the results of cell microscopic imaging to those of standard frozen section and paraffin section pathology to determine the accuracy and potential advantages of the new imaging technology in real-time intraoperative assessment of surgical margins | Within 7 days after the operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fan | Contact | 13601052226 | zhqfan@bjmu.edu.cn |
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|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000072662 | Margins of Excision |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
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