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

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ClinicalTrials.gov Identifier: NCT04068077
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborator:
Apollo Medical Optics, Ltd.
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

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.


Condition or disease Intervention/treatment
Amyloidosis Device: ApolloVue™ S100 image system, Viper1-S003

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis
Actual Study Start Date : March 8, 2019
Estimated Primary Completion Date : November 4, 2019
Estimated Study Completion Date : November 4, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Experimental
Patients with amyloidosis and other indistinguishable diseases
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.




Primary Outcome Measures :
  1. Number of subjects with clear tissue characteristics of amyloidosis and/or other pigmented diseases in tomograms [ Time Frame: 1 year ]
    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.

  2. Number of subjects with the distinction between skin lesion and normal skin in tomograms [ Time Frame: 1 year ]
    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.


Secondary Outcome Measures :
  1. Number of subjects with the distinction between amyloidosis and other pigmented diseases in tomograms [ Time Frame: 1 year ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population from experimental group will be selected.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068077


Contacts
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Contact: Hsin Cheng,, CRA +886-2-87523198 ext 103 hsin@mdamo.com

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei City, Beitou District, Taiwan, 11217
Contact: Ding-Dar Lee, M.D., Ph. D.    +886-938593530    ddlee@vghtpe.gov.tw   
Principal Investigator: Ding-Dar Lee, M.D., Ph. D.         
Sub-Investigator: Yun-Ting Chang, M.D., Ph. D.         
Sub-Investigator: Chih-Chiang Chen, M.D., Ph. D.         
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Apollo Medical Optics, Ltd.
Investigators
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Principal Investigator: Ding-Dar Lee, M.D., Ph. D. Taipei Veterans General Hospital, Taiwan
Publications:
Chiu YK, Chen WL, Tsai CT, Yang CH, and Huang SL. A high en-face resolution AS-OCT providing quantitative ability to measure layered corneal opacities. European Conferences on Biomedical Optics, Munich Germany, 25-29, 2017.

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04068077    
Other Study ID Numbers: 2018-10-019A
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
optical coherence tomography (OCT)
amyloidosis
pigmented diseases
skin diseases
dermatology
pathology
H&E stain
Additional relevant MeSH terms:
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Skin Diseases
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases