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A prospective clinical study investigating the use of the Histolog Scanner for intraoperative assessment of surgical margins in patients undergoing breast-conserving surgery for histologically confirmed breast cancer. The Histolog Scanner operates on the principle of confocal microscopy and enables non-destructive evaluation of specimen margins. The specimen will subsequently be sent for standard histopathological assessment; therefore, the use of this method does not pose any risk to the patient, as the diagnostic and therapeutic pathway for breast cancer will not be altered.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histolog scanner | Device | The aim of the project is a prospective pilot evaluation in a cohort of 20 patients to determine whether the use of the Histolog Scanner may, in the future, reduce the number of reoperations by identifying positive surgical margins already during the initial procedure.The specimen will subsequently be sent for standard histopathological assessment; therefore, the use of this method does not pose any risk to the patient, as the diagnostic and therapeutic pathway for breast cancer will not be altered. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of reoperation rate (%) | Intraoperative assessment of the surgical specimen using the Histolog Scanner in breast cancer patients undergoing breast-conserving surgery reduces the likelihood of reoperation for an R1 resection, i.e., tumor involvement at the surgical margin. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients indicated for breast-conserving surgery in Silesian Hospital in Opava for breast cancer confirmed by core-cut biopsy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Žatecký, MD, PhD | Contact | +420776193203 | janzatecky.jz@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Silesian Hospital in Opava | Opava | Czechia |
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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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