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NCT Number: NCT07402616

Ex Vivo Cutaneous SCC

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Linnea Langhans, MD, PhD

CONTACT

[email protected]

35454755

Linnea Langhans, MD, PhD

PRINCIPAL_INVESTIGATOR

Martin Garset-Zamani, MD, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ex vivo 3D ultrasonography

Diagnostic Test

Surgical specimens scanned with 3D ultrasonography

Primary outcomes

  1. Deep margin distance

    Time frame: Within 10-14 days from enrollment

    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).

Secondary outcomes

  1. Depth of invasion

    Time frame: Within 10-14 days from enrollment

    Distance perpendicular to the granular layer of the epidermis of the specimen to the deepest point of tumor invasion, measured in millimeters.

  2. Tumor size in 3 dimensions measured in mm with ultrasound and histopathology

    Time frame: Within 10-14 days from enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Linnea Langhans, MD, PhD

CONTACT

[email protected]

35454755

Martin Garset-Zamani, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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