Cutaneous Squamous Cell CarcinomaNCT07402616
Ex Vivo Cutaneous SCC
A study testing ex vivo 3D ultrasonography in people with Cutaneous Squamous Cell Carcinoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cutaneous Squamous Cell Carcinoma
- What is being tested?
- ex vivo 3D ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2026to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with primary cutaneous squamous cell carcinoma.
Who cannot join
- Carcinomas located on the eyelids, vulva, penis, or perianal.
- Tumors with an anticipated excision larger than 60mm.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Martin Garset-Zamani, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Linnea Langhans, MD, PhD, 35454755, linnea.langhans@regionh.dk
Martin Garset-Zamani, MD, PhD
About this study
Official title: Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma
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.
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Being tested
- ex vivo 3D ultrasonography
- Keywords
- cSCC, 3D ultrasound, ultrasonography, ex vivo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ex vivo 3D ultrasonographyDiagnostic test
Surgical specimens scanned with 3D ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| 3D Ultrasonography | Experimental | Not described Receives: Diagnostic Test: ex vivo 3D ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deep margin distance
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).
Measured: Within 10-14 days from enrollment
Secondary outcomes (2)
Depth of invasion
Distance perpendicular to the granular layer of the epidermis of the specimen to the deepest point of tumor invasion, measured in millimeters.
Measured: Within 10-14 days from enrollment
Tumor size in 3 dimensions measured in mm with ultrasound and histopathology
Measured: Within 10-14 days from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Feb 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linnea Langhans, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Tobias Todsen, MD, PhD, Study chair, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402616
- Sponsor's protocol ID
- Ex vivo cutaneous SCC
- Status last verified
- Feb 2026
- First submitted
- 14 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of 3D ex Vivo Ultrasonography for Post-operative Evaluation of Tumor Margins in Cutaneous Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07402616
- Acronym / sponsor ID
- Ex vivo cutaneous SCC
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Keywords
- cSCC, 3D ultrasound, ultrasonography, ex vivo
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 11 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Ultrasonography | Experimental | Diagnostic Test: ex vivo 3D ultrasonography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with primary cutaneous squamous cell carcinoma.
Key exclusion criteria (2 listed)
- Carcinomas located on the eyelids, vulva, penis, or perianal.
- Tumors with an anticipated excision larger than 60mm.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ex vivo 3D ultrasonographySurgical specimens scanned with 3D ultrasonography | Diagnostic test | 3D Ultrasonography |
Primary outcome
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).
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Garset-Zamani, MD, PhD contact
Tobias Todsen, MD, PhD study chair
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ex vivo 3D ultrasonography in people with Cutaneous Squamous Cell Carcinoma, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Linnea Langhans, MD, PhD (35454755, linnea.langhans@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deep margin distance (time frame: Within 10-14 days from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.