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

Plain Language Summary

Simplified for easier understanding

This study is collecting surgically removed skin tissue from people with cutaneous squamous cell carcinoma (a common type of skin cancer that starts in the outer layer of skin) to study the tumor in a laboratory setting. By analyzing tumor tissue directly after removal, researchers hope to learn more about how this cancer behaves, how it resists treatment, and what new therapies might target it more effectively. **You may be eligible if...** - You are an adult who has been diagnosed with primary cutaneous squamous cell carcinoma (skin cancer arising in your own skin, not spread from elsewhere) - You are having your tumor surgically removed as part of your standard care **You may NOT be eligible if...** - Your tumor is located on sensitive areas such as the eyelids, vulva, penis, or perianal region - The expected size of surgical removal is larger than approximately 2.5 inches (60mm) in diameter - Your doctor determines participation is not appropriate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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