Cutaneous Squamous Cell Carcinoma
Conditions
Keywords
cSCC, 3D ultrasound, ultrasonography, ex vivo
Brief summary
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.
Interventions
DIAGNOSTIC_TESTex vivo 3D ultrasonography
Surgical specimens scanned with 3D ultrasonography
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with primary cutaneous squamous cell carcinoma.
Exclusion criteria
* Carcinomas located on the eyelids, vulva, penis, or perianal. * Tumors with an anticipated excision larger than 60mm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deep margin distance | Within 10-14 days from enrollment | 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
| Measure | Time frame | Description |
|---|---|---|
| Depth of invasion | Within 10-14 days from enrollment | 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 | Within 10-14 days from enrollment | — |
Countries
Denmark
Contacts
CONTACTLinnea Langhans, MD, PhD
CONTACTMartin Garset-Zamani, MD, PhD
STUDY_CHAIRTobias Todsen, MD, PhD
Rigshospitalet, Denmark
Outcome results
None listed