Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis

Study Overview
=================
Brief Summary
-----------------
Amyloidosis is caused by the misfolding protein accumulated in tissue, which affects the function of the organs. In addition to the primary cutaneous amyloidosis, a skin lesion may also appear in another classification - systemic amyloidosis. Physicians can confirm diagnosis of the above classification by skin biopsy. Primary cutaneous amyloidosis is common in Asia and South America. In Taiwan, 80 people are diagnosed with primary cutaneous amyloidosis in every 100,000 people. Among the disease, macular amyloidosis and lichen amyloidosis are the most common subtypes. Primary cutaneous amyloidosis can cause severe itching, pigmentation, and skin keratosis, and further affect the social behavior of patients. The etiology of primary cutaneous amyloidosis is currently unclear, possibly due to genetic variations or viral infection. Typical primary cutaneous amyloidosis can be diagnosed by clinical manifestations, however, if the location or appearance of a lesion is atypical, the disease will be indistinguishable from other pigmented diseases, and further need a biopsy. If physicians can use a rapider and more accurate assistance tool to evaluate disease first, it will improve the accuracy of clinical diagnosis, relieve patient of suffering from biopsy, and further use medical resources more effectively. Optical coherence tomography (OCT) is a kind of optical imaging medical system. It generates images by detecting the variations in refractive indexes of the various components in soft tissues. Apollo Medical Optics, Ltd. (AMO)'s OCT device (ApolloVue™ S100 image system, Viper1-S003) acquires real-time in vivo skin tissue tomograms with cellular resolution which provides a non-invasive, non-radioactive and rapid image acquisition. In this study, AMO's OCT will be used to observe features in tomograms of primary cutaneous amyloidosis and that of other indistinguishable diseases, compare the correspondence of tomograms with pathological sections, induct features in tomograms specific to primary cutaneous amyloidosis and other indistinguishable diseases, and further establish an OCT database of primary cutaneous amyloidosis.

Official Title
-----------------
Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis

Conditions
-----------------
Amyloidosis

Intervention / Treatment
-----------------
* Device: ApolloVue™ S100 image system, Viper1-S003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with suspected primary cutaneous amyloidosis and other indistinguishable diseases Patients with no open wounds 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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental<br>Patients with amyloidosis and other indistinguishable diseases | Device: ApolloVue™ S100 image system, Viper1-S003<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with clear tissue characteristics of amyloidosis and/or other pigmented diseases in tomograms | 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 amyloidosis and other pigmented diseases at study completion. | 1 year | 
| Number of subjects with the distinction between skin lesion and normal skin in tomograms | 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 normal skin by the OCT at study completion. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with the distinction between amyloidosis and other pigmented diseases in tomograms | Number of subjects with the distinction between amyloidosis and other pigmented diseases in tomograms will be compared to that with no distinction to verify the effect of the OCT on distinguishing amyloidosis from other pigmented diseases at study completion. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
optical coherence tomography (OCT), amyloidosis, pigmented diseases, skin diseases, dermatology, pathology, H&E stain