Early Feasibility Study: Application of OCT Imaging in Dermatology

Mackay Memorial Hospital

Status: Completed

Conditions: Skin Diseases

Treatments: Device: ApolloVue™ S100 image system, Viper1-S003

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04066582

17CT062Be

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

123 participants in 1 patient group

Experimental

Description:

Suspected skin inflammations or skin tumors

Treatment:

Device: ApolloVue™ S100 image system, Viper1-S003