RecruitingNot ApplicableNCT07402616

Ex Vivo Cutaneous SCC

Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma


Sponsor

Rigshospitalet, Denmark

Enrollment

30 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria1

  • Adults with primary cutaneous squamous cell carcinoma.

Exclusion Criteria2

  • Carcinomas located on the eyelids, vulva, penis, or perianal.
  • Tumors with an anticipated excision larger than 60mm.

Interventions

DIAGNOSTIC_TESTex vivo 3D ultrasonography

Surgical specimens scanned with 3D ultrasonography


Locations(1)

Rigshospitalet

Copenhagen, Denmark

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NCT07402616


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