Clinical trial NCT04406454: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Skin
Nevus
Keywords: Optical Coherence Tomograohy
Healthy volunteer
Non-invasive image system
Cellular level resolution
Full-Field OCT
Nevus
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: Apollo Medical Optics, Ltd
First posted: 2020-05-28
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population from healthy volunteers will be selected.

Brief summary: ApolloVue® S100 Image System is a medical device class II. 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. All age will be recruited.
2. Both genders will be recruited.
3. 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)
4. Has healthy skin at 5 anatomical locations including face, back, dorsal forearm, volar forearm, and calf.
5. Has at least a nevus without superficial scales and crusting
6. Willing to provide informed consent

Exclusion Criteria:

1. Individuals who have a systemic skin disorder.
2. Individuals who have a history of severe skin condition
3. 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.
4. Not willing to cooperate with methods and related procedures of this trial/study

Primary outcomes:
measure: 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.
timeFrame: 2 years
measure: Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%).
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei city
country: Taiwan
facility: Taipei Veterans General Hospital
state: Beitou District
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Ding-Dar Lee, M.D., Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.
citation: Adabi S, Hosseinzadeh M, Noei S, Conforto S, Daveluy S, Clayton A, Mehregan D, Nasiriavanaki M. Universal in vivo Textural Model for Human Skin based on Optical Coherence Tomograms. Sci Rep. 2017 Dec 20;7(1):17912. doi: 10.1038/s41598-017-17398-8.