Deep Learning on 3D Cellular-resolution Tomogram

NCT04679961 | Completed

• 2 other identifiers: 20STW2-01MOST 108-2634-F-002-014 -
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

Skin biopsy is the main method to diagnose skin tumors, skin inflammation, and pigmented diseases. However, biopsy is an invasive method that can cause wounds and scars. Optical coherent tomography (OCT) technology is a fast, non-invasive, non-radioactive, and label-free imaging method. This technology generates real-time images of living tissue by detecting the variations in the refractive indexes of various components in soft tissues. Recently, there is a breakthrough progress that the newly designed ultrahigh resolution OCT can provide in vivo cellular resolution similar to histopathological sections in the high magnification. In our previous clinical trial "Early feasibility study: application of OCT imaging in dermatology" (approved by IRB of MacKay Memorial Hospital, no. 17CT062Be), it showed characteristic features of different skin inflammatory diseases and tumors can be distinguished successfully in tomograms. There were no adverse event or serious adverse event in this trial. Artificial intelligence technologies have been used widely in the image analysis in recent years. Hence, we aim to collect OCT tomograms of common skin inflammatory diseases, skin tumors, and pigmented diseases, and compare with normal skin for machine learning. We expect the integration of tomograms with deep learning artificial intelligence may assist identifying histological features in these images and provide new alternative way for non-invasive diagnosis in dermatology.

Conditions

Skin Diseases

Keywords

Optical coherence tomography (OCT); artificial intelligence; deep learning; skin diseases; dermatology

Outcome Measures

Primary Outcomes (2)

• Number of subjects of tomograms that can be analyzed by artificial intelligence techniques

  Number of subjects of tomograms that can be analyzed by artificial intelligence techniques (including machine learning and deep learning) will be compared to that cannot be analyzed to identify the feasibility of using artificial intelligence techniques to analyze tomograms at study completion.

  2.5 years

• Number of subjects with the similarity results of interpreting tomograms between artificial intelligence and experts

  Number of subjects with the similarity results of interpreting tomograms between artificial intelligence and experts will be compared to that with no similarity to verify whether artificial intelligence interpretation are comparable with gold standard methods expert interpretation at study completion.

  2.5 years

Secondary Outcomes (1)

• Number of subjects with the correlation between tomograms and gold standard methods, eg. existing clinical images or pathological images.

  2.5 years

Study Arms (2)

Experimental

1. Epidermal inflammations, including eczematous diseases and psoriasis 2. Epidermal tumors, including benign tumors and malignant tumors 3. Pigmented diseases, including hypopigmentation and hyperpigmentation

Device: ApolloVue® S100 Image System (Apollo Medical Optics)

Control

Healthy skin

Device: ApolloVue® S100 Image System (Apollo Medical Optics)

Interventions

ApolloVue® S100 Image System (Apollo Medical Optics) 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 both experimental group and control group.

Also known as: 510(K) Number: K201552 (class II)

Control; Experimental

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population from both experimental group and control group will be selected.

You may qualify if:

• Experimental group:
• Adults aged 20 years or older
• Non-treat lesion of epidermal inflammatory disease: dermatitis and psoriasis
• Benign tumors: seborrheic keratosis and nevus
• Malignant tumors: actinic keratosis (AK), melanoma, basal cell carcinoma (BCC), Bowen's disease, squamous cell carcinoma (SCC), and extramammary Paget's disease (EMPD)
• Pigmented diseases: solar lentigo, melasma, and vitiligo
• Control group:
• The healthy face (exposed site) and inner forearm (unexposed site) skin of epidermal tumors and pigmented diseases of the above experimental group were used as a control group, excluding epidermal inflammatory diseases.

You may not qualify if:

• Experimental group:
• Minors aged under 20 years
• Suspected a transcutaneous infectious disease, including infections such as bacteria, fungi, viruses, and parasites.
• All skin tumors that are in the subcutaneous tissue
• All skin lesions are open wounds
• All skin lesions are in a location that is difficult to scan
• Not willing to cooperate with methods and related procedures of this study
• Vulnerable populations, including prisoners, pregnant women, handicapped, mentally disabled, known AIDS patients, and homelessness
• Control group:
• Minors under 20 years of age.
• Epidermal inflammatory disease
• Suspected a transcutaneous infectious disease, including infections such as bacteria, fungi, viruses, and parasites.
• Individuals who have a systemic skin disorder.
• Individuals who have a history of severe skin condition
• Individuals with surgeries/cosmetic surgeries/micro cosmetic surgery (eg. cosmetic injections and/or laser etc.) on healthy skin at face and inner forearm in last 3 months and a physician determine the surgery will affect outcome of the OCT images.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead
• National Taiwan University: collaborator

Study Sites (1)

Mackay Memorial Hospital

New Taipei City, Tamsui District, 25160, Taiwan

Location

Related Publications (6)

• Schneider SL, Kohli I, Hamzavi IH, Council ML, Rossi AM, Ozog DM. Emerging imaging technologies in dermatology: Part I: Basic principles. J Am Acad Dermatol. 2019 Apr;80(4):1114-1120. doi: 10.1016/j.jaad.2018.11.042. Epub 2018 Dec 4.

  PMID: 30528311 BACKGROUND

• Schneider SL, Kohli I, Hamzavi IH, Council ML, Rossi AM, Ozog DM. Emerging imaging technologies in dermatology: Part II: Applications and limitations. J Am Acad Dermatol. 2019 Apr;80(4):1121-1131. doi: 10.1016/j.jaad.2018.11.043. Epub 2018 Dec 4.

  PMID: 30528310 BACKGROUND

• Dubois A, Levecq O, Azimani H, Siret D, Barut A, Suppa M, Del Marmol V, Malvehy J, Cinotti E, Rubegni P, Perrot JL. Line-field confocal optical coherence tomography for high-resolution noninvasive imaging of skin tumors. J Biomed Opt. 2018 Oct;23(10):1-9. doi: 10.1117/1.JBO.23.10.106007.

  PMID: 30353716 BACKGROUND

• Wang YJ, Huang YK, Wang JY, Wu YH. In vivo characterization of large cell acanthoma by cellular resolution optical coherent tomography. Photodiagnosis Photodyn Ther. 2019 Jun;26:199-202. doi: 10.1016/j.pdpdt.2019.03.020. Epub 2019 Mar 30. No abstract available.

  PMID: 30940575 BACKGROUND

• Tsai CC, Chang CK, Hsu KY, Ho TS, Lin MY, Tjiu JW, Huang SL. Full-depth epidermis tomography using a Mirau-based full-field optical coherence tomography. Biomed Opt Express. 2014 Aug 8;5(9):3001-10. doi: 10.1364/BOE.5.003001. eCollection 2014 Sep 1.

  PMID: 25401013 BACKGROUND

• Chang CK, Tsai CC, Hsu WY, Chen JS, Liao YH, Sheen YS, Hong JB, Lin MY, Tjiu JW, Huang SL. Errata: Segmentation of nucleus and cytoplasm of a single cell in three-dimensional tomogram using optical coherence tomography. J Biomed Opt. 2017 Mar 1;22(3):39801. doi: 10.1117/1.JBO.22.3.039801. No abstract available.

  PMID: 28300273 BACKGROUND

MeSH Terms

Conditions

Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Study Officials

• Wu, MD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 22, 2020
• Study Start: December 21, 2020
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: March 17, 2023

Record last verified: 2023-03

Locations

TW (1)