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Completed

NCT Number: NCT04066582

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.

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Key information

Conditions

Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mackay Memorial Hospital

New Taipei City, Tamsui District, 25160, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ApolloVue™ S100 image system, Viper1-S003

Device

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mackay Memorial Hospital

Other

Collaborators

  • Apollo Medical Optics, Ltd

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 26, 2019
Registry last updated
Apr 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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