Clinical trial NCT04066582: Early Feasibility Study: Application of OCT Imaging in Dermatology
Official title: Early Feasibility Study: Application of OCT Imaging in Dermatology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Skin Diseases
Keywords: optical coherence tomography (OCT)
dermatology
skin diseases
pathology
H&E stain
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Apollo Medical Optics, Ltd
First posted: 2019-08-26
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population from experimental group will be selected.

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.


Eligibility 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

Primary outcomes:
measure: Number of subjects with clear tissue characteristics of skin diseases and/or normal skin in tomograms
timeFrame: 2 years
measure: Number of subjects with the distinction between skin lesion and normal skin in tomograms
timeFrame: 2 years
Secondary outcomes:
measure: Number of subjects with clear tissue stratification of skin diseases and/or normal skin in tomograms
timeFrame: 2 years
measure: Number of subjects with the similarity of tissue characteristics, tissue stratification, and tissue thickness between tomograms and H&E stain
timeFrame: 2 years
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Mackay Memorial Hospital
state: Tamsui District
Study officials:
affiliation: Mackay Memorial Hospital
name: Yen-Jen Wang, MD
role: PRINCIPAL_INVESTIGATOR
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