Skin LesionNCT05068310
Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors
An observational study of Skin Lesion and Skin Cancer, run by Apollo Medical Optics, Ltd at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin Lesion, Skin Cancer
- What is being tested?
- Cellular resolution full-field optical coherence tomography, Confocal microscopy and Optical coherence tomography imaging
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 21 Oct 2021to Feb 2025
- Phase
- Observational
- 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
Study population: Patients with suspicious skin lesion/tumor that requires skin biopsy or complete excision
Who may be able to join
- 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
Who cannot join
- Patients aged < 18 years
- Any unstable medical or psychological conditions
- Unwillingness to participate in this study including the assessment with high resolution OCT
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hsin Cheng contact
Germany1 site, 1 recruiting
- Recruiting
CMB COLLEGIUM MEDICUM BERLIN GmbH
Berlin
Martina Ulrich, MD
About this study
Official title: Applicability of a Cellular Level Resolution Full-field OCT Image System (AMO, Taiwan) for the Diagnosis of Pigmented and Non-pigmented Skin Tumors
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.
Read the detailed description
The new high resolution OCT scanner (ApolloVue® S100 Image System, Apollo Medical Optics, Ltd. (AMO), Taiwan) is a CE-certified device, which allows non invasive imaging of the skin at high resolution. ApolloVue® S100 System provides two-dimensional, cross-sectional and en-face images which allow the real-time visualization of the skin and the assessment by physicians. OCT is an interferometry technique, which can differentiate the back- scattered light from different layers within the sample and reconstruct the microstructure of tissue. ApolloVue S100 System uses a single-crystal fiber light source (750 nm wavelength), thus allowing cellular images with an axial resolution around one micron can be achieved. The full-field OCT (FF-OCT) system utilize a camera for parallel detection to increases the scanning speed. Furthermore, by scanning an en-face image with the coherence and confocal gates matched, it does not suffer from depth-of-field limitations present in standard OCT and can achieve micron scale transverse image resolutions. AMO FF-OCT provides both high-resolution en face and B-scan imaging with decent scanning speed. Compare to traditional full-field OCT or confocal microscopy, the cross- sectional image can be shown in real-time without reconstruction after whole volume is scanned. With a simple optical switch, user can switch between two modes to improve the efficiency of lesion examination and gather more structure information. ApolloVue® S100 System is a contact imaging system with a guiding system which provides wide-range real- time color imaging to guide OCT measurement on precise position. While a measurement starts, the cart can be moved to the patient and adjust the height by lifter which covers sitting and lying positions. Then, user can precisely align the probe to a lesion by moving the arm with the guiding video which is shown on monitor. Once the lesion is aligned, user can switch the system from guiding mode to OCT modes and perform OCT scans and save the images. After the scans, user can switch back guiding mode for next position. The modes can be selected through the buttons on the probe or the computer. OCT images and the scanning positions on the guiding image will be recorded simultaneously for following up the lesion.The ApolloVue S100 System will enable the user to:
- Acquire cross-sectional or en-face 2-dimensional OCT images of sub-surface tissue.
- Acquire 2-dimentional OCT images of sub-surface tissue.
- Real-time image guiding system for OCT measurement and recording position.
- Read and manage OCT image data and annotations
- Export OCT images as PNG and as DICOM compliant image files
- Conditions
- Skin Lesion, Skin Cancer
- Being tested
- Cellular resolution full-field optical coherence tomography, Confocal microscopy, Optical coherence tomography imaging, Dermoscopy imaging
- Medical subject headings
- Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cellular resolution full-field optical coherence tomographyDevice
Device: ApolloVue® S100 Image System
Confocal microscopyDevice
Device: Vivascope® will be used for skin imaging for a subset of skin lesions.
Optical coherence tomography imagingDevice
Device: Vivosight® will be used for skin imaging for a subset of skin lesions.
Dermoscopy imagingDevice
Device: Dermoscopy imaging will be conducted using but not limited to dermoscope DermLite FotoX®
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors | Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors who are scheduled for skin biopsy or excision Receives: Device: Cellular resolution full-field optical coherence tomography; Device: Confocal microscopy; Device: Optical coherence tomography imaging; Device: Dermoscopy imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the disease features of pigmented and non-pigmented skin lesions
This is an observational study. The morphologic patterns of pigmented and non-pigmented skin lesions will be examined (% lesions that demonstrate descriptor examined).
Measured: 1.5 year
Secondary outcomes (1)
Diagnostic accuracy of pigmented and non-pigmented skin lesions
The diagnostic accuracy (sensitivity and specificity) of pigmented and non-pigmented skin lesions will be determined.
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start21 Oct 2021
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apollo Medical Optics, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martina Ulrich, MD, Principal investigator, CMB COLLEGIUM MEDICUM BERLIN GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068310
- Sponsor's protocol ID
- 21SDE2-01-001-V1A1
- Status last verified
- Dec 2024
- First submitted
- 20 Sep 2021
- Last updated
- 31 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applicability of a Cellular Level Resolution Full-field OCT Image System (AMO, Taiwan) for the Diagnosis of Pigmented and Non-pigmented Skin Tumors
- ClinicalTrials.gov ID
- NCT05068310
- Acronym / sponsor ID
- 21SDE2-01-001-V1A1
- Conditions
- Skin Lesion, Skin Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Apollo Medical Optics, LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 5 Oct 2021 (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.
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.
Detailed description
The new high resolution OCT scanner (ApolloVue® S100 Image System, Apollo Medical Optics, Ltd. (AMO), Taiwan) is a CE-certified device, which allows non invasive imaging of the skin at high resolution. ApolloVue® S100 System provides two-dimensional, cross-sectional and en-face images which allow the real-time visualization of the skin and the assessment by physicians. OCT is an interferometry technique, which can differentiate the back- scattered light from different layers within the sample and reconstruct the microstructure of tissue. ApolloVue S100 System uses a single-crystal fiber light source (750 nm wavelength), thus allowing cellular images with an axial resolution around one micron can be achieved. The full-field OCT (FF-OCT) system utilize a camera for parallel detection to increases the scanning speed. Furthermore, by scanning an en-face image with the coherence and confocal gates matched, it does not suffer from depth-of-field limitations present in standard OCT and can achieve micron scale transverse image resolutions. AMO FF-OCT provides both high-resolution en face and B-scan imaging with decent scanning speed. Compare to traditional full-field OCT or confocal microscopy, the cross- sectional image can be shown in real-time without reconstruction after whole volume is scanned. With a simple optical switch, user can switch between two modes to improve the efficiency of lesion examination and gather more structure information. ApolloVue® S100 System is a contact imaging system with a guiding system which provides wide-range real- time color imaging to guide OCT measurement on precise position. While a measurement starts, the cart can be moved to the patient and adjust the height by lifter which covers sitting and lying positions. Then, user can precisely align the probe to a lesion by moving the arm with the guiding video which is shown on monitor. Once the lesion is aligned, user can switch the system from guiding mode to OCT modes and perform OCT scans and save the images. After the scans, user can switch back guiding mode for next position. The modes can be selected through the buttons on the probe or the computer. OCT images and the scanning positions on the guiding image will be recorded simultaneously for following up the lesion.The ApolloVue S100 System will enable the user to:
- Acquire cross-sectional or en-face 2-dimensional OCT images of sub-surface tissue.
- Acquire 2-dimentional OCT images of sub-surface tissue.
- Real-time image guiding system for OCT measurement and recording position.
- Read and manage OCT image data and annotations
- Export OCT images as PNG and as DICOM compliant image files
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors | – | Device: Cellular resolution full-field optical coherence tomography, Device: Confocal microscopy, Device: Optical coherence tomography imaging, Device: Dermoscopy imagingPatients with non-melanocytic lesions and tumors and pigmented lesions and tumors who are scheduled for skin biopsy or excision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicious skin lesion/tumor that requires skin biopsy or complete excision
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Patients aged < 18 years
- Any unstable medical or psychological conditions
- Unwillingness to participate in this study including the assessment with high resolution OCT
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 |
|---|---|---|
| Cellular resolution full-field optical coherence tomographyDevice: ApolloVue® S100 Image System | Device | Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors |
| Confocal microscopyDevice: Vivascope® will be used for skin imaging for a subset of skin lesions. | Device | Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors |
| Optical coherence tomography imagingDevice: Vivosight® will be used for skin imaging for a subset of skin lesions. | Device | Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors |
| Dermoscopy imagingDevice: Dermoscopy imaging will be conducted using but not limited to dermoscope DermLite FotoX® | Device | Patients with non-melanocytic lesions and tumors and pigmented lesions and tumors |
Primary outcome
Characterization of the disease features of pigmented and non-pigmented skin lesions
Time frame: 1.5 year
This is an observational study. The morphologic patterns of pigmented and non-pigmented skin lesions will be examined (% lesions that demonstrate descriptor examined).
1 secondary outcome
Diagnostic accuracy of pigmented and non-pigmented skin lesions
Time frame: 1.5 year
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 31 Dec 2024.
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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.
Hsin Cheng contact
Martina Ulrich, MD principal investigator
CMB COLLEGIUM MEDICUM BERLIN GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Lesion and Skin Cancer, run by Apollo Medical Optics, Ltd at 1 site in Germany.
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 4 inclusion and 3 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 31 Dec 2024. 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 Germany. 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 Emily Tsai, PhD (886-2-87523198 ext. 609, emily@mdamo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of the disease features of pigmented and non-pigmented skin lesions (time frame: 1.5 year). 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 31 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.