Ex Vivo Cutaneous SCC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ex vivo 3D ultrasonography.
- Who it may be relevant to
- Registry conditions: Cutaneous Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma
Overview
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 test ex vivo 3D ultrasonography
Surgical specimens scanned with 3D ultrasonography
Primary outcome measures
- Deep margin distance [Time frame: Within 10-14 days from enrollment]
Secondary outcome measures (2)
- Depth of invasion [Time frame: Within 10-14 days from enrollment]
- Tumor size in 3 dimensions measured in mm with ultrasound and histopathology [Time frame: Within 10-14 days from enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Denmark · 1 center
- Rigshospitalet — Copenhagen
Identifiers
NCT: NCT07402616 · Ex vivo cutaneous SCC