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

NCT04068077 | Completed

• 1 other identifier: 2018-10-019A
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloidosis

Keywords

optical coherence tomography (OCT); amyloidosis; pigmented diseases; skin diseases; dermatology; pathology; H&E stain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of subjects with the distinction between amyloidosis and other pigmented diseases in tomograms

  1 year

Study Arms (1)

Experimental

Patients with amyloidosis and other indistinguishable diseases

Device: ApolloVue™ S100 image system, Viper1-S003

Interventions

ApolloVue™ S100 image system, Viper1-S003 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 experimental group.

Experimental

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population from experimental group will be selected.

You may qualify if:

• Patients diagnosed with suspected primary cutaneous amyloidosis and other indistinguishable diseases
• Patients with no open wounds

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• Apollo Medical Optics, Ltd: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Beitou District, 11217, Taiwan

Location

Related Publications (11)

• Chuang YY, Lee DD, Lin CS, Chang YJ, Tanaka M, Chang YT, Liu HN. Characteristic dermoscopic features of primary cutaneous amyloidosis: a study of 35 cases. Br J Dermatol. 2012 Sep;167(3):548-54. doi: 10.1111/j.1365-2133.2012.11066.x.

  PMID: 22632408 BACKGROUND

• Lei W, Ai-E X. Reflectance confocal microscopy for the characterization of primary cutaneous amyloidosis: a pilot study. Skin Res Technol. 2017 Aug;23(3):441-443. doi: 10.1111/srt.12343. Epub 2017 Jan 12. No abstract available.

  PMID: 28083882 BACKGROUND

• Esmat SM, Fawzi MM, Gawdat HI, Ali HS, Sayed SS. Efficacy of different modes of fractional CO2 laser in the treatment of primary cutaneous amyloidosis: A randomized clinical trial. Lasers Surg Med. 2015 Jul;47(5):388-95. doi: 10.1002/lsm.22361. Epub 2015 May 6.

  PMID: 25946210 BACKGROUND

• Al Yahya RS. Treatment of primary cutaneous amyloidosis with laser: a review of the literature. Lasers Med Sci. 2016 Jul;31(5):1027-35. doi: 10.1007/s10103-016-1917-8. Epub 2016 Mar 16.

  PMID: 26984345 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

• 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.

  BACKGROUND

• Wang SC, Hsu CY, Yang TT, Jheng DY, Yang TI, Ho TS, Huang SL. Laser-diode pumped glass-clad Ti:sapphire crystal fiber laser. Opt Lett. 2016 Jul 15;41(14):3217-20. doi: 10.1364/OL.41.003217.

  PMID: 27420499 BACKGROUND

• Wang SC, Yang TI, Jheng DY, Hsu CY, Yang TT, Ho TS, Huang SL. Broadband and high-brightness light source: glass-clad Ti:sapphire crystal fiber. Opt Lett. 2015 Dec 1;40(23):5594-7. doi: 10.1364/OL.40.005594.

  PMID: 26625059 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

• Ho TS, Yeh P, Tsai CC, Hsu KY, Huang SL. Spectroscopic measurement of absorptive thin films by spectral-domain optical coherence tomography. Opt Express. 2014 Mar 10;22(5):5675-83. doi: 10.1364/OE.22.005675.

  PMID: 24663908 BACKGROUND

• Cheng NC, Hsieh TH, Wang YT, Lai CC, Chang CK, Lin MY, Huang DW, Tjiu JW, Huang SL. Cell death detection by quantitative three-dimensional single-cell tomography. Biomed Opt Express. 2012 Sep 1;3(9):2111-20. doi: 10.1364/BOE.3.002111. Epub 2012 Aug 13.

  PMID: 23024905 BACKGROUND

MeSH Terms

Conditions

Amyloidosis; Skin Diseases

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ding-Dar Lee, M.D., Ph. D.

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: March 8, 2019
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

TW (1)