Clinical trial · Observational
Multimodal Imaging of Basal Cell Carcinoma: A Usability Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinoma of Skin | Skin Basal Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-invasive multimodal skin imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- BCC Participants
- description
- 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.
- interventionNames
- Device: Non-invasive multimodal skin imaging
Primary outcomes (1)
- measure
- Time consumption per imaging modality
- timeFrame
- Single study visit, approximately 40 minutes per lesion
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: Inability to provide informed consent
References
Publications (13)
- RESULTBozsanyi 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 37959375
- RESULTSiskou 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 37373588
- RESULTQin 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 33638227
- RESULTWang 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 31460903
- RESULTGust 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 35205830
- RESULTSuppa 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.