Rigshospitalet
Copenhagen, 2100, Denmark
Location status: Recruiting
Location contact
Linnea Langhans, MD, PhD
CONTACT
Linnea Langhans, MD, PhD
PRINCIPAL_INVESTIGATOR
Martin Garset-Zamani, MD, PhD
SUB_INVESTIGATOR
NCT Number: NCT07402616
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Location status: Recruiting
Linnea Langhans, MD, PhD
CONTACT
Linnea Langhans, MD, PhD
PRINCIPAL_INVESTIGATOR
Martin Garset-Zamani, MD, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical specimens scanned with 3D ultrasonography
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).
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.
Time frame: Within 10-14 days from enrollment
Contact information is provided by the study sponsor or research team.
Linnea Langhans, MD, PhD
CONTACT
Martin Garset-Zamani, MD, PhD
CONTACT
Rigshospitalet, Denmark
Other
Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma
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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