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

NCT04068077 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2021-04-27

No results posted yet for this study

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.

Conditions

  • Amyloidosis

Interventions

DEVICE

ApolloVue™ S100 image system, Viper1-S003

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.

Sponsors & Collaborators

  • Apollo Medical Optics, Ltd

    collaborator INDUSTRY

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Ding-Dar Lee, M.D., Ph. D. · Taipei Veterans General Hospital, Taiwan

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2019-12-19
Completion
2019-12-19

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068077 on ClinicalTrials.gov