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

Taipei Veterans General Hospital

Status: Completed

Conditions: Healthy Skin; Nevus

Treatments: Device: ApolloVue® S100 Image System

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04406454

2020-01-001A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Heathy volunteers

Description:

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.

Treatment:

Device: ApolloVue® S100 Image System