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This is a prospective study including patients ( ≥ 18 years) referred for surgical treatment of primary cutaneous squamous cell carcinoma at the Department of Plastic Surgery, Rigshospitalet. After written and informed consent, patients will undergo standard surgical excision, followed by ex vivo 3D ultrasonography of the specimen using a 3Sonic device connected to a high-frequency ultrasound machine. This will create 3D ultrasound tomographic scans which will be interpreted by one investigator blinded to histopathology. The investigated outcomes will primarily be the deep margin distance. This will be compared to histopathology, where a pathologist - blinded to the ultrasonography results - will slice the entire specimen parallel to the ultrasound images. A third investigator will then match the histopathology images to the ultrasound images for correlation of the measured deep margins.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D Ultrasonography | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ex vivo 3D ultrasonography | Diagnostic Test | Surgical specimens scanned with 3D ultrasonography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Deep margin distance | The minimum deep margins in each ultrasound or histopathology tumor slide measured in millimeters from the deepest tumor border to the closest deep border of the healthy tissue (if present). | Within 10-14 days from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Depth of invasion | Distance perpendicular to the granular layer of the epidermis of the specimen to the deepest point of tumor invasion, measured in millimeters. | Within 10-14 days from enrollment |
| Tumor size in 3 dimensions measured in mm with ultrasound and histopathology |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linnea Langhans, MD, PhD | Contact | 35454755 | linnea.langhans@regionh.dk | |
| Martin Garset-Zamani, MD, PhD | Contact | martin.garset-zamani@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Tobias Todsen, MD, PhD | Rigshospitalet, Denmark | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| Within 10-14 days from enrollment |