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Recruiting Not applicable

Ex Vivo Cutaneous SCC

NCT07402616 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2026-02-01
Last updated
2026-02-11

Condition(s) studied

Cutaneous Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

ex vivo 3D ultrasonography

ex vivo 3D ultrasonography: Surgical specimens scanned with 3D ultrasonography

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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.

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07402616 on ClinicalTrials.gov ↗ ← All trials in Denmark