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

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.

Study Overview

• Status: Completed
• Conditions: Nevus; Healthy Skin
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Taiwan
  • Beitou District
    • Taipei city, Beitou District, Taiwan, 11217
      • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The population from healthy volunteers will be selected.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heathy volunteers; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Scanning efficiency = total number of quality images/total number of images obtained x 100%.; Scanning efficiency ≧ 50%	2 years
Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%).	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	2 years
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 required < 20 minutes for each body site except for nevus. Time required < 40 minutes for a nevus including image guiding.	2 years

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: Apollo Medical Optics, Ltd
• Investigators: Principal Investigator: Ding-Dar Lee, M.D., Ph. D, Taipei Veterans General Hospital, Taiwan

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: May 24, 2020
• First Posted (Actual): May 28, 2020

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 12, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Healthy volunteer; Nevus; Full-Field OCT; Non-invasive image system; Optical Coherence Tomograohy; Cellular level resolution
• Other Study ID Numbers: 2020-01-001A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No