Early Feasibility Study: Application of OCT Imaging in Dermatology

Completed

• Conditions: Skin Diseases
• Interventions: Device: ApolloVue™ S100 image system, Viper1-S003

• Registration Number: NCT04066582
• Lead Sponsor: Mackay Memorial Hospital

Brief Summary

Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture biological images from within optical scattering media (e.g., biological tissue). A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use.

AMO has developed an in-vivo OCT scanning system prototype based on the clinical needs and potential applications. This study is designed as an early feasibility study aiming for validation of AMO's in-vivo OCT scanning system in dermatology through collaboration with Mackay Memorial Hospital. The OCT can provide cellular-resolution (\<1μm in lateral and axial directions) images which can be utilized to identify organelles. A high-resolution OCT has the characteristics of non-invasive, label-free, real-time, cellular resolution with high tissue penetration depth that are highly valuable for clinical use.

The proposed scenario in this study is to collecting OCT images of skins with suspicious lesion including tumor, inflammatory diseases or pigment alteration as well as normal skin by using AMO's in vivo OCT imaging system. By using traditional pathological biopsy images or dermoscopic images as gold standard references, investigators will try to identify different characteristics in OCT images of skin with suspicious lesion including tumor, inflammatory diseases, or pigment alteration as well as normal skins.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-29
• Study First Submitted: 2019-08-19
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-26
• Primary Completion: 2019-10-02
• Study Completion: 2019-10-02
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-21
• Last Update Posted: 2021-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

Inclusion Criteria

• A patient who is fully aware of the trial and can sign the inform consent form himself/herself
• Patients with suspected skin tumors or skin inflammations
• Patients diagnosed for biopsy
• Patients with no open wounds in the tumor or inflamed position

Exclusion Criteria

• Patients with a transcutaneous infectious disease
• Patients under the age of 20
• Vulnerable populations, including: pregnant women, handicapped, and homelessness
• Patient cannot cooperate in examination
• Patients with skin tumors that are in the subcutaneous tissue

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental	ApolloVue™ S100 image system, Viper1-S003	Suspected skin inflammations or skin tumors

Primary Outcome Measures

Name	Time	Method
Number of subjects with clear tissue characteristics of skin diseases and/or normal skin in tomograms	2 years	Number of subjects with clear tissue characteristics of tomograms will be compared to that with unclear tissue characteristics to identify the effect of the OCT on scanning skin at study completion.
Number of subjects with the distinction between skin lesion and normal skin in tomograms	2 years	Number of subjects with the distinction between skin lesion and normal skin in tomograms will be compared to that with no distinction to verify the specific diseases that can be distinguished from others by the OCT at study completion.

Secondary Outcome Measures

Name	Time	Method
Number of subjects with clear tissue stratification of skin diseases and/or normal skin in tomograms	2 years	Number of subjects with clear tissue stratification, eg. dermal-epidermal junction, of tomograms will be compared to that with unclear tissue stratification to identify the effect of the OCT on scanning skin at study completion.
Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H&E stain	2 years	Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H\&E stain will be compared to that with no similarity to verify whether the tomograms are comparable with gold standard methods H\&E stain images at study completion.

Trial Locations

Locations (1)

Mackay Memorial Hospital; 🇨🇳 New Taipei City, Tamsui District, Taiwan