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

NCT04406454 | Completed DMC

• 1 other identifier: 2020-01-001A
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Skin; Nevus

Keywords

Optical Coherence Tomograohy; Healthy volunteer; Non-invasive image system; Cellular level resolution; Full-Field OCT; Nevus

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

ApolloVue® S100 Image System DEVICE

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.

Heathy volunteers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population from healthy volunteers will be selected.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Apollo Medical Optics, Ltd: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 3377516 BACKGROUND

• 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.

  PMID: 29263332 BACKGROUND

MeSH Terms

Conditions

Nevus

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ding-Dar Lee, M.D., Ph. D

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2020
• First Posted: May 28, 2020
• Study Start: July 6, 2020
• Primary Completion: September 1, 2021
• Study Completion: February 8, 2022
• Last Updated: November 14, 2023

Record last verified: 2023-11

Locations

TW (1)