The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability
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|ClinicalTrials.gov Identifier: NCT04406454|
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : February 12, 2021
|Condition or disease||Intervention/treatment|
|Healthy Skin Nevus||Device: ApolloVue® S100 Image System|
The OCT can provide cellular resolution (~1μm in lateral and axial directions) images. A cellular resolution OCT has the characteristics of non-invasive, non-radioactive, labelfree, real-time and high tissue penetration depth that are highly valuable for clinical use. This technology allows visualization of important structural features such as the epidermis and dermis and the epidermal-dermal junction. OCT has the advantage of generating cross-sectional images, like the orientation of pathology slides.
The ApolloVue® S100 Image System is intended to be used as a non-invasive imaging tool in the evaluation of external human skin tissue microstructure by providing two-dimensional, crosssectional (B-scan) and en face (E-scan) real-time visualization for assessment by physicians to support in forming a clinical judgment. For the ApolloVue® S100 Image System image, both cross-sectional view and en face view can be obtained to assist physicians' diagnosis. With both views, physicians can obtain important spatial information in regards to the skin. Besides, the ApolloVue® S100 Image System is equipped with an image guiding system which provides a high-resolution dermatoscope like image, for the positioning of skin sites for optical biopsies.
In this protocol, it is proposed to study the optical imaging features of healthy human skin and nevi and the evaluation of usability. We propose to recruit 60 subjects for such a trial. Healthy volunteers will be approached and consented to this protocol. The volunteers will be imaged.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||The Application of Non-invasive and Cellular Level Resolution Fullfield Optical Coherence Tomography: Establishment and Analysis of Subcutaneous Cellular Level Image Database of Anatomical Locations in Healthy Volunteers and Evaluation of Usability|
|Actual Study Start Date :||July 6, 2020|
|Estimated Primary Completion Date :||June 8, 2021|
|Estimated Study Completion Date :||June 8, 2022|
Patients has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, calf and at least a nevus without superficial scales and crusting.
Device: ApolloVue® S100 Image System
The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.
- Determine the average scanning success rate of obtaining at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively. [ Time Frame: 2 years ]
- Scanning efficiency = total number of quality images/total number of images obtained x 100%.
- Scanning efficiency ≧ 50%
- Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%). [ Time Frame: 2 years ]
The purpose of this evaluation is to validate that the ApolloVue® S100 Image System delivers non-invasive skin image features.
Required features will be analyzed for each group, including age, skin type and anatomical location.
The features need to meet the following requirement in each 500 x 400 µm2 image for B-scan and in each 500 x 500 μm2 image for E-scan.
A. Identification of keratinocyte in ≧ 80% of images (B-scan only)
B. Identification of stratum corneum in ≧ 80% of images
C. Identification of epidermis in ≧ 80% of images
D. Identification of dermis in ≧ 80% of images
E. Identification of EDJ in ≧ 80% of images
F. Identification of collagen in ≧ 80% of images (B-scan only)
G. Identification of melanin in ≧ 80% of images
- Determine time required to obtain at least 3 quality OCT images of B-scan and E-scan with 4 depths for each skin site, respectively. [ Time Frame: 2 years ]
Time required < 20 minutes for each body site except for nevus.
Time required < 40 minutes for a nevus including image guiding.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406454
|Contact: Hsin Cheng, CRA||+886-2-87523198 ext email@example.com|
|Taipei Veterans General Hospital||Recruiting|
|Taipei city, Beitou District, Taiwan, 11217|
|Contact: Ding-Dar Lee, M.D., Ph. D +886-938593530 firstname.lastname@example.org|
|Principal Investigator: Ding-Dar Lee, M.D., Ph. D.|
|Sub-Investigator: Chih-Chiang Chen, M.D., Ph. D.|
|Sub-Investigator: Yun-Ting Chang, M.D., Ph. D.|
|Sub-Investigator: Cheng-Yuan Li, M.D.|
|Principal Investigator:||Ding-Dar Lee, M.D., Ph. D||Taipei Veterans General Hospital, Taiwan|