3D ultrasound of removed cutaneous squamous cell carcinoma specimens
Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma
For adults having surgery to remove cutaneous squamous cell carcinoma, this will try ex vivo 3D ultrasound of the removed specimen to see if it can accurately measure the deep margin compared with standard pathology.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07402616 on ClinicalTrials.gov |
What this trial studies
Adults referred for surgical excision of primary cutaneous squamous cell carcinoma will have their routine excised specimen scanned ex vivo with a 3Sonic device connected to a high-frequency ultrasound to produce 3D tomographic images. One investigator, blinded to pathology, will interpret the ultrasound images and record the measured deep margin distance. A pathologist, blinded to the ultrasound results, will slice the entire specimen parallel to the ultrasound images and measure the histologic deep margin. A third investigator will match the ultrasound and histology images to compare the measured deep margins.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for surgical excision of a primary cutaneous squamous cell carcinoma, excluding tumors on the eyelids, vulva, penis, or perianal area and those requiring excisions larger than 60 mm.
Not a fit: Patients with tumors in the excluded locations, tumors likely requiring excisions larger than 60 mm, or non-primary lesions are unlikely to benefit from this specific imaging approach.
Why it matters
Potential benefit: If successful, this technique could provide faster, non-destructive information about deep margins and help identify inadequate margins to reduce the need for re-excision.
How similar studies have performed: Ultrasound has been used previously for skin cancer imaging and margin guidance, but ex vivo 3D tomographic matching to complete histopathology is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Linnea Langhans, MD, PhD
- Email: linnea.langhans@regionh.dk
- Phone: 35454755
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.