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

Taipei Veterans General Hospital

Status: Completed

Conditions: Amyloidosis

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

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04068077

2018-10-019A

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Experimental

Description:

Patients with amyloidosis and other indistinguishable diseases

Treatment:

Device: ApolloVue™ S100 image system, Viper1-S003