NCT07402616

Ex Vivo Cutaneous SCC

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Squamous Cell Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	ex vivo 3D ultrasonography	Surgical specimens scanned with 3D ultrasonography

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-01-01
• Completion: 2027-09-01
• First posted: 2026-02-11
• Last updated: 2026-02-11

Locations

1 site across 1 country: Denmark