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

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Taipei Veterans General Hospital, Taiwan
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Updated on 19 February 2024
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Summary

The objective of this protocol is to image skin of healthy volunteers and to evaluate the performance of full-field optical coherence tomography (FF-OCT) device - the ApolloVue S100 Image System in imaging skin microstructures of healthy skin at different anatomical locations and nevi for different skin types and different age and to evaluate usability of the ApolloVue S100 Image System.

Description

The OCT can provide cellular resolution (~1m 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.

Details
Condition Pigmented nevus, Nevus, Healthy Skin
Age 100 years and younger
Treatment ApolloVue® S100 Image System
Clinical Study IdentifierNCT04406454
SponsorTaipei Veterans General Hospital, Taiwan
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

All age will be recruited
Both genders will be recruited
All skin types will be recruited. Skin type I-VI (Fitzpatrick scale)
Type I always burns, never tans (unexposed skin color: white)
Type II usually burns, tans less than average (with difficulty) (unexposed skin color: white)
Type III sometimes mild burns, tans about average (unexposed skin color: white)
Type IV rarely burns, tans more than average (with easy) (unexposed skin color: white)
Type V very rarely burns (unexposed skin color: brown)
Type VI never burns (unexposed skin color: black)
Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, and calf
Has at least a nevus without superficial scales and crusting
Willing to provide informed consent

Exclusion Criteria

Individuals who have a systemic skin disorder
Individuals who have a history of severe skin condition
Individuals with surgeries/cosmetic surgeries/micro cosmetic surgery (eg. cosmetic injections and/or laser etc.) on healthy skin at the 5 anatomical locations and nevi (see inclusion criteria 5) in last 12 months and a physician determine the surgery will affect outcome of the OCT images
Not willing to cooperate with methods and related procedures of this trial/study
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