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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

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ClinicalTrials.gov Identifier: NCT04406454
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborator:
Apollo Medical Optics, Ltd.
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
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.

Condition or disease Intervention/treatment
Healthy Skin Nevus Device: ApolloVue® S100 Image System

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Estimated Study Start Date : June 8, 2020
Estimated Primary Completion Date : June 8, 2021
Estimated Study Completion Date : June 8, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Moles

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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. [ Time Frame: 2 years ]
    • Scanning efficiency = total number of quality images/total number of images obtained x 100%.
    • Scanning efficiency ≧ 50%

  2. Evaluator identification of each feature will be assessed (number of correctly identified feature/number of total features x 100%). [ Time Frame: 2 years ]

    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


  3. 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 Frame: 2 years ]
    • Time required < 10 minutes.

  4. Determine time required from taking dermatoscope images to saving OCT images for all skin sites by an operator. [ Time Frame: 2 years ]
    • Time required < 60 minutes.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The population from healthy volunteers will be selected.
Criteria

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

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): NCT04406454


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

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei city, Beitou District, Taiwan, 11217
Contact: Ding-Dar Lee, M.D., Ph. D    +886-938593530    ddlee@vghtpe.gov.tw   
Principal Investigator: Ding-Dar Lee, M.D., Ph. D.         
Sub-Investigator: Chih-Chiang Chen, M.D., Ph. D.         
Sub-Investigator: Yun-Ting Chang, M.D., Ph. D.         
Sub-Investigator: Cheng-Yuan Li, M.D.         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Apollo Medical Optics, Ltd.
Investigators
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Principal Investigator: Ding-Dar Lee, M.D., Ph. D Taipei Veterans General Hospital, Taiwan
Publications:
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04406454    
Other Study ID Numbers: 2020-01-001A
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
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 Taipei Veterans General Hospital, Taiwan:
Optical Coherence Tomograohy
Healthy volunteer
Non-invasive image system
Cellular level resolution
Full-Field OCT
Nevus