About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults with primary cutaneous squamous cell carcinoma.
Disqualifiers
Carcinomas located on the eyelids, vulva, penis, or perianal.
Tumors with an anticipated excision larger than 60mm.
Trial design
Single group
Treatments tested in this trial
ex vivo 3D ultrasonography
Diagnostic testSurgical specimens scanned with 3D ultrasonography
Treatment groups
Trial outcomes
Primary outcomes
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).
Secondary outcomes
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.
Tumor size in 3 dimensions measured in mm with ultrasound and histopathology
Sponsors and contacts
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