Early Feasibility Study: Application of OCT Imaging in Dermatology

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.

Study Overview

• Status: Completed
• Conditions: Skin Diseases
• Intervention / Treatment: Device: ApolloVue™ S100 image system, Viper1-S003

• Study Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Taiwan
  • Tamsui District
    • New Taipei City, Tamsui District, Taiwan, 25160
      • Mackay Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population from experimental group will be selected.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental; Suspected skin inflammations or skin tumors	Device: ApolloVue™ S100 image system, Viper1-S003; The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with clear tissue characteristics of skin diseases and/or normal skin in tomograms	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.	2 years
Number of subjects with the distinction between skin lesion and normal skin in tomograms	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with clear tissue stratification of skin diseases and/or normal skin in tomograms	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.	2 years
Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H&E stain	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.	2 years

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Collaborators: Apollo Medical Optics, Ltd
• Investigators: Principal Investigator: Yen-Jen Wang, MD, Mackay Memorial Hospital

Publications and helpful links

General Publications

• Chang CK, Tsai CC, Hsu WY, Chen JS, Liao YH, Sheen YS, Hong JB, Lin MY, Tjiu JW, Huang SL. Errata: Segmentation of nucleus and cytoplasm of a single cell in three-dimensional tomogram using optical coherence tomography. J Biomed Opt. 2017 Mar 1;22(3):39801. doi: 10.1117/1.JBO.22.3.039801. No abstract available.
• Chiu YK, Chen WL, Tsai CT, Yang CH, and Huang SL. A high en-face resolution AS-OCT providing quantitative ability to measure layered corneal opacities. European Conferences on Biomedical Optics, Munich Germany, 25-29, 2017.
• Wang SC, Hsu CY, Yang TT, Jheng DY, Yang TI, Ho TS, Huang SL. Laser-diode pumped glass-clad Ti:sapphire crystal fiber laser. Opt Lett. 2016 Jul 15;41(14):3217-20. doi: 10.1364/OL.41.003217.
• Wang SC, Yang TI, Jheng DY, Hsu CY, Yang TT, Ho TS, Huang SL. Broadband and high-brightness light source: glass-clad Ti:sapphire crystal fiber. Opt Lett. 2015 Dec 1;40(23):5594-7. doi: 10.1364/OL.40.005594.
• Tsai CC, Chang CK, Hsu KY, Ho TS, Lin MY, Tjiu JW, Huang SL. Full-depth epidermis tomography using a Mirau-based full-field optical coherence tomography. Biomed Opt Express. 2014 Aug 8;5(9):3001-10. doi: 10.1364/BOE.5.003001. eCollection 2014 Sep 1.
• Ho TS, Yeh P, Tsai CC, Hsu KY, Huang SL. Spectroscopic measurement of absorptive thin films by spectral-domain optical coherence tomography. Opt Express. 2014 Mar 10;22(5):5675-83. doi: 10.1364/OE.22.005675.
• Cheng NC, Hsieh TH, Wang YT, Lai CC, Chang CK, Lin MY, Huang DW, Tjiu JW, Huang SL. Cell death detection by quantitative three-dimensional single-cell tomography. Biomed Opt Express. 2012 Sep 1;3(9):2111-20. doi: 10.1364/BOE.3.002111. Epub 2012 Aug 13.
• Wang YJ, Huang YK, Wang JY, Wu YH. In vivo characterization of large cell acanthoma by cellular resolution optical coherent tomography. Photodiagnosis Photodyn Ther. 2019 Jun;26:199-202. doi: 10.1016/j.pdpdt.2019.03.020. Epub 2019 Mar 30. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2018
• Primary Completion (Actual): October 2, 2019
• Study Completion (Actual): October 2, 2019

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 22, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: dermatology; skin diseases; optical coherence tomography (OCT); pathology; H&E stain
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 17CT062Be

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