NCT07803406

Brief Summary

The goal of this observational study is to evaluate the time efficiency and practical usability of three non-invasive skin imaging tools in adults (18 years and older) with basal cell carcinoma (BCC), the most common type of skin cancer. The main questions it aims to answer are: How long does it take to perform each scan (optical coherence tomography, line-field confocal optical coherence tomography, and high-frequency ultrasound)? How comfortable is each scan for participants? How well do the imaging tools work across different areas of the body? Participants will undergo one study visit of approximately 40 minutes, during which three non-invasive skin scans are performed on the skin lesion. Each scan uses a different imaging tool. Participants will also complete a short questionnaire about their experience. No biopsies or other invasive procedures are performed as part of the study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Sep 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Sep 2026Nov 2027

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

September 14, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2027

Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

9 months

First QC Date

August 31, 2026

Last Update Submit

August 31, 2026

Conditions

Basal Cell Carcinoma of Skin

Keywords

basal cell carcinomaNon-invasive imagingAI-assisted imagingLine-field confocal optical coherence tomographyHigh-frequency ultrasoundArtificial intelligenceDermoscopyMultimodal imaging

Outcome Measures

Primary Outcomes (1)

  • Time consumption per imaging modality

    Time consumption measured in minutes per patient for each modality (OCT, LC-OCT, and HFUS) and in total, recorded from the start of device set-up to the completion of image acquisition and documentation.

    Single study visit, approximately 40 minutes per lesion

Secondary Outcomes (3)

  • Patient-reported discomfort during imaging

    Assessed immediately after completion of all imaging procedures at the single study visit.

  • Practical feasibility of scanning across anatomical regions

    Assessed immediately after completion of all imaging procedures at the single study visit.

  • Image quality across anatomical regions

    Assessed immediately after completion of all imaging procedures at the single study visit.

Other Outcomes (1)

  • Agreement between AI-assisted imaging and histopathological morphology

    Assessed at histological follow-up, up to 12 weeks after the study visit.

Study Arms (1)

BCC Participants

Adults aged 18 years or older with histologically confirmed or clinically suspected basal cell carcinoma scheduled for standard clinical management at the Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark. Each participant undergoes a single study visit comprising sequential non-invasive imaging with three AI-assisted modalities: optical coherence tomography (OCT), line-field confocal optical coherence tomography (LC-OCT), and high-frequency ultrasound (HFUS). No interventions are performed. All imaging is adjunct to standard care.

Device: Non-invasive multimodal skin imaging

Interventions

Non-invasive multimodal skin imagingDEVICE

Sequential non-invasive imaging of basal cell carcinoma lesions using three AI-assisted imaging modalities: OCT (VivoSight Dx, Michelson Diagnostics), LC-OCT (deepLive, DAMAE Medical), and HFUS (SkinScanner, Dermus). All devices are CE-marked Class IIa medical devices used within their approved intended purpose. Each device incorporates an AI module to support image interpretation. Imaging is performed at a single study visit and is strictly observational and adjunct to standard clinical care. No tissue is removed and no therapeutic intervention is performed.

Also known as: Optical coherence tomography (OCT), Line-field confocal optical coherence tomography (LC-OCT), High-frequency ultrasound (HFUS)
BCC Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 18 years or older with histologically confirmed or clinically suspected basal cell carcinoma attending the Department of Dermatology, Bispebjerg Hospital, Copenhagen, Denmark, as part of their routine clinical care.

You may qualify if:

  • Age 18 years or older Presence of a histologically confirmed or clinically suspected basal cell carcinoma lesion scheduled for standard clinical management Ability to provide written informed consent

You may not qualify if:

  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Bispebjerg Hospital

Copenhagen, Denmark, 2400, Denmark

RECRUITING

Related Publications (13)

  • Bozsanyi S, Boostani M, Farkas K, Hamilton-Meikle P, Varga NN, Szabo B, Vasanits F, Kuroli E, Meznerics FA, Lorincz K, Hollo P, Banvolgyi A, Wikonkal NM, Paragh G, Kiss N. Optically Guided High-Frequency Ultrasound to Differentiate High-Risk Basal Cell Carcinoma Subtypes: A Single-Centre Prospective Study. J Clin Med. 2023 Nov 3;12(21):6910. doi: 10.3390/jcm12216910.

    PMID: 37959375RESULT

  • Siskou S, Pasquali P, Trakatelli M. High Frequency Ultrasound of Basal Cell Carcinomas: Ultrasonographic Features and Histological Subtypes, a Retrospective Study of 100 Tumors. J Clin Med. 2023 Jun 7;12(12):3893. doi: 10.3390/jcm12123893.

    PMID: 37373588RESULT

  • Qin J, Wang J, Zhu Q, Liu J, Gao Y, Wang Y, Jin H. Usefulness of high-frequency ultrasound in differentiating basal cell carcinoma from common benign pigmented skin tumors. Skin Res Technol. 2021 Sep;27(5):766-773. doi: 10.1111/srt.13012. Epub 2021 Feb 27.

    PMID: 33638227RESULT

  • Wang SQ, Liu J, Zhu QL, Zhao CY, Qu T, Li F, Wortsman X, Jin HZ. High-frequency ultrasound features of basal cell carcinoma and its association with histological recurrence risk. Chin Med J (Engl). 2019 Sep 5;132(17):2021-2026. doi: 10.1097/CM9.0000000000000369.

    PMID: 31460903RESULT

  • Gust C, Schuh S, Welzel J, Daxenberger F, Hartmann D, French LE, Ruini C, Sattler EC. Line-Field Confocal Optical Coherence Tomography Increases the Diagnostic Accuracy and Confidence for Basal Cell Carcinoma in Equivocal Lesions: A Prospective Study. Cancers (Basel). 2022 Feb 21;14(4):1082. doi: 10.3390/cancers14041082.

    PMID: 35205830RESULT

  • Suppa M, Fontaine M, Dejonckheere G, Cinotti E, Yelamos O, Diet G, Tognetti L, Miyamoto M, Orte Cano C, Perez-Anker J, Panagiotou V, Trepant AL, Monnier J, Berot V, Puig S, Rubegni P, Malvehy J, Perrot JL, Del Marmol V. Line-field confocal optical coherence tomography of basal cell carcinoma: a descriptive study. J Eur Acad Dermatol Venereol. 2021 May;35(5):1099-1110. doi: 10.1111/jdv.17078. Epub 2020 Dec 29.

    PMID: 33398911RESULT

  • Latriglia F, Ogien J, Tavernier C, Fischman S, Suppa M, Perrot JL, Dubois A. Line-Field Confocal Optical Coherence Tomography (LC-OCT) for Skin Imaging in Dermatology. Life (Basel). 2023 Nov 28;13(12):2268. doi: 10.3390/life13122268.

    PMID: 38137869RESULT

  • Fischman S, Viel T, Perrot JL, Perez-Anker J, Suppa M, Cinotti E, Lenoir C, Orte Cano C, Welzel J, Schuh S, Sattler EC, Del Marmol V, Rubegni P, Dragotto M, Cioppa V, Falcinelli F, Cappilli S, Challe S, Tavernier C, Malvehy J, Tognetti L; LC-OCT Reviewers Consortium. AI-assisted basal cell carcinoma diagnosis with LC-OCT: A multicentric retrospective study. J Eur Acad Dermatol Venereol. 2026 Jun;40(6):1059-1068. doi: 10.1111/jdv.70099. Epub 2025 Oct 19.

    PMID: 41109970RESULT

  • Jerjes W, Hamdoon Z, Rashed D, Hopper C. In Vivo Optical Coherence Tomography for the Detection, Subtyping, and Margin Assessment of Facial Basal Cell Carcinoma: A Comparative Study with Histopathology. J Clin Med. 2025 Feb 1;14(3):949. doi: 10.3390/jcm14030949.

    PMID: 39941619RESULT

  • Adan F, Nelemans PJ, Essers BAB, Brinkhuizen T, Dodemont SRP, Kessels JPHM, Quaedvlieg PJF, Dermont GJ, Winnepenninckx VJL, Abdul Hamid M, Kelleners-Smeets NWJ, Mosterd K. Optical coherence tomography versus punch biopsy for diagnosis of basal cell carcinoma: a multicentre, randomised, non-inferiority trial. Lancet Oncol. 2022 Aug;23(8):1087-1096. doi: 10.1016/S1470-2045(22)00347-3. Epub 2022 Jul 11.

    PMID: 35835136RESULT

  • Lodish MB, Yuan B, Levy I, Braunstein GD, Lyssikatos C, Salpea P, Szarek E, Karageorgiadis AS, Belyavskaya E, Raygada M, Faucz FR, Izzat L, Brain C, Gardner J, Quezado M, Carney JA, Lupski JR, Stratakis CA. Germline PRKACA amplification causes variable phenotypes that may depend on the extent of the genomic defect: molecular mechanisms and clinical presentations. Eur J Endocrinol. 2015 Jun;172(6):803-11. doi: 10.1530/EJE-14-1154.

    PMID: 25924874RESULT

  • Kafle TR, Kattel B, Lane SD, Wang T, Zhao H, Chan WL. Charge Transfer Exciton and Spin Flipping at Organic-Transition-Metal Dichalcogenide Interfaces. ACS Nano. 2017 Oct 24;11(10):10184-10192. doi: 10.1021/acsnano.7b04751. Epub 2017 Oct 10.

    PMID: 28985468RESULT

  • Wortsman X. Ultrasound in Skin Cancer: Why, How, and When to Use It? Cancers (Basel). 2024 Sep 27;16(19):3301. doi: 10.3390/cancers16193301.

    PMID: 39409920RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Merete Hædersdal, Professor

    Bispebjerg Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Otto Dideriksen, MD

CONTACT

+45 29103585otto.dideriksen@regionh.dk

Emilie Ravn, Project Nurse

CONTACT

+45 38635362emilie.sylvestersen.ravn.02@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Medical Doctor

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

September 14, 2026

Primary Completion (Estimated)

June 25, 2027

Study Completion (Estimated)

November 5, 2027

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared due to Danish data protection legislation (GDPR) and the Danish Data Protection Act, which restrict transfer and sharing of pseudonymized health data from Danish public hospitals. Data will be stored securely on the Capital Region of Denmark's servers for 10 years following study completion.

Locations

DK(1)