Clinical trial · Observational
Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
Applicability of a Cellular Level Resolution Full-field OCT Image System (AMO, Taiwan) for the Diagnosis of Pigmented and Non-pigmented Skin Tumors
- 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 incidence of skin cancer has been continuously increasing over the past decades und the number of non melanoma skin cancer is well as melanoma is still going to increase. Invasive biopsy and histological examination represents the gold standard in diagnosis of benign and malignant skin tumors. However, novel technologies such as reflectance confocal microscopy (RCM) and optical coherence tomography (OCT) have been introduced in dermatology. Multiple studies have shown the applicability of both technologies for diagnosis of skin tumors as well as other skin diseases and to increase the specificity of diagnosis resulting in the reduction of unnecessary biopsies. New technological developments resulted in a high resolution OCT scanner (AMO, Taiwan), which allows vertical and horizontal evaluation (3D) of the skin at cellular resolution and up to a depth of around 400 μm and thus combines the advantages of both above mentioned techniques. ApolloVue® S100 Image System is a FDA-cleared 510(k) Class II medical device. Other non-invasive imaging method (reflectance confocal microscopy and conventional optical coherence tomography) will be used to evaluate a subset of skin lesions.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Skin Lesion | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cellular resolution full-field optical coherence tomography | Device | — | UNRESOLVED |
| Confocal microscopy | Device | — | UNRESOLVED |
| Dermoscopy imaging | Device | — | UNRESOLVED |
| Optical coherence tomography imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors
- description
- Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors who are scheduled for skin biopsy or excision
- interventionNames
- Device: Cellular resolution full-field optical coherence tomography
- Device: Confocal microscopy
- Device: Optical coherence tomography imaging
- Device: Dermoscopy imaging
Primary outcomes (1)
- measure
- Characterization of the disease features of pigmented and non-pigmented skin lesions
- timeFrame
- 1.5 year
- description
- This is an observational study. The morphologic patterns of pigmented and non-pigmented skin lesions will be examined (% lesions that demonstrate descriptor examined).
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged \> 18 years * Willingness to participate in this study including the assessment with high resolution OCT * Skin lesion/tumor with suspicion for skin cancer that requires skin biopsy or complete excision * Benign skin tumor that is scheduled for excision due to suspicion, irritation or for cosmetic reason Exclusion Criteria: * Patients aged \< 18 years * Any unstable medical or psychological conditions * Unwillingness to participate in this study including the assessment with high resolution OCT
References
Publications (0)
Data not yet available