Applicability of a Cellular Resolution Full-field OCT Image System for Pigmented and Non-pigmented Skin Tumors

Skin Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05068310
• Other study ID #: 21SDE2-01-001-V1A1
• Status: Recruiting
• Start date: October 21, 2021
• Est. completion date: September 2023

Study information

• Verified date: February 2023
• Source: Apollo Medical Optics, Ltd
• Contact: Emily Tsai, PhD
• Phone: 886-2-87523198
• Email: emily[@]mdamo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

1. Acquire cross-sectional or en-face 2-dimensional OCT images of sub-surface tissue.

2. Acquire 2-dimentional OCT images of sub-surface tissue.

3. Real-time image guiding system for OCT measurement and recording position.

4. Read and manage OCT image data and annotations

5. Export OCT images as PNG and as DICOM compliant image files

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Skin Cancer
• Skin Lesion
• Skin Neoplasms

Intervention

Device:
• Cellular resolution full-field optical coherence tomography
Device: ApolloVue® S100 Image System
• Confocal microscopy
Device: Vivascope® will be used for skin imaging for a subset of skin lesions.
• Optical coherence tomography imaging
Device: Vivosight® will be used for skin imaging for a subset of skin lesions.
• Dermoscopy imaging
Device: Dermoscopy imaging will be conducted using but not limited to dermoscope DermLite FotoX®

Locations

Country	Name	City	State
Germany	CMB COLLEGIUM MEDICUM BERLIN GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Apollo Medical Optics, Ltd

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	1.5 year
Secondary	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.	1.5 year