Ex Vivo Cutaneous SCC
Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
February 11, 2026
February 1, 2026
11 months
January 14, 2026
February 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Within 10-14 days from enrollment
Secondary Outcomes (2)
Depth of invasion
Within 10-14 days from enrollment
Tumor size in 3 dimensions measured in mm with ultrasound and histopathology
Within 10-14 days from enrollment
Study Arms (1)
3D Ultrasonography
EXPERIMENTALInterventions
Surgical specimens scanned with 3D ultrasonography
Eligibility Criteria
You may qualify if:
- Adults with primary cutaneous squamous cell carcinoma.
You may not qualify if:
- Carcinomas located on the eyelids, vulva, penis, or perianal.
- Tumors with an anticipated excision larger than 60mm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rigshospitalet
Copenhagen, 2100, Denmark
Study Officials
- STUDY CHAIR
Tobias Todsen, MD, PhD
Rigshospitalet, Denmark
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
January 14, 2026
First Posted
February 11, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
February 11, 2026
Record last verified: 2026-02