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Early Feasibility Study: Application of OCT Imaging in Dermatology

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ClinicalTrials.gov Identifier: NCT04066582
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborator:
Apollo Medical Optics, Ltd.
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Skin Diseases Device: ApolloVue™ S100 image system, Viper1-S003

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Feasibility Study: Application of OCT Imaging in Dermatology
Actual Study Start Date : January 29, 2018
Estimated Primary Completion Date : December 24, 2019
Estimated Study Completion Date : December 24, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

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.




Primary Outcome Measures :
  1. Number of subjects with clear tissue characteristics of skin diseases and/or normal skin in tomograms [ Time Frame: 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.

  2. Number of subjects with the distinction between skin lesion and normal skin in tomograms [ Time Frame: 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 :
  1. Number of subjects with clear tissue stratification of skin diseases and/or normal skin in tomograms [ Time Frame: 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.

  2. Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H&E stain [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population from experimental group will be selected.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04066582


Contacts
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Contact: Hsin Cheng, CRA +886-2-87523198 ext 103 hsin@mdamo.com

Locations
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Taiwan
Mackay Memorial Hospital Recruiting
New Taipei City, Tamsui District, Taiwan, 25160
Contact: Yen-Jen Wang, MD    +886-919549930    yenjen4208@gmail.com   
Principal Investigator: Yen-Jen Wang, MD         
Sub-Investigator: Yu-Hung Wu, MD         
Sub-Investigator: Jen-Yu Wang, MD         
Sponsors and Collaborators
Mackay Memorial Hospital
Apollo Medical Optics, Ltd.
Investigators
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Principal Investigator: Yen-Jen Wang, MD Mackay Memorial Hospital
Publications of Results:
Other Publications:
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.

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Responsible Party: Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT04066582    
Other Study ID Numbers: 17CT062Be
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mackay Memorial Hospital:
optical coherence tomography (OCT)
dermatology
skin diseases
pathology
H&E stain
Additional relevant MeSH terms:
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Skin Diseases