AmyloidosisNCT04068077
Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis
An observational study of Amyloidosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Amyloidosis
- What is being tested?
- ApolloVue™ S100 image system, Viper1-S003
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2019to 19 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population from experimental group will be selected.
Who may be able to join
- Patients diagnosed with suspected primary cutaneous amyloidosis and other indistinguishable diseases
- Patients with no open wounds
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- ApolloVue™ S100 image system, Viper1-S003
- Keywords
- optical coherence tomography (OCT), amyloidosis, pigmented diseases, skin diseases, dermatology, pathology, H&E stain
- Medical subject headings
- Amyloidosis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApolloVue™ S100 image system, Viper1-S003Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients with amyloidosis and other indistinguishable diseases Receives: Device: ApolloVue™ S100 image system, Viper1-S003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start8 Mar 2019
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for AmyloidosisStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- Apollo Medical Optics, Ltd
- Responsible party
- Sponsor
- Investigators
- Ding-Dar Lee, M.D., Ph. D., Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068077
- Sponsor's protocol ID
- 2018-10-019A
- Status last verified
- Apr 2021
- First submitted
- 22 Aug 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 22632408Lei 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.
PubMed 28083882Esmat 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.
PubMed 25946210Al 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.
PubMed 26984345Chang 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.
PubMed 28300273Chiu 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.
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.
PubMed 27420499Wang 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.
PubMed 26625059Tsai 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.
PubMed 25401013Ho 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.
PubMed 24663908Cheng 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.
PubMed 23024905
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of High Resolution Optical Coherence Tomography in Skin Disease: Amyloidosis and Differential Diagnosis
- ClinicalTrials.gov ID
- NCT04068077
- Acronym / sponsor ID
- 2018-10-019A
- Conditions
- Amyloidosis
- Keywords
- optical coherence tomography (OCT), amyloidosis, pigmented diseases, skin diseases, dermatology, pathology, H&E stain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- Apollo Medical Optics, Ltd
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Device: ApolloVue™ S100 image system, Viper1-S003Patients with amyloidosis and other indistinguishable diseases |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population from experimental group will be selected.
Key inclusion criteria (2 listed)
- Patients diagnosed with suspected primary cutaneous amyloidosis and other indistinguishable diseases
- Patients with no open wounds
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApolloVue™ S100 image system, Viper1-S003The 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. | Device | Experimental |
Primary outcome
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.
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.
1 secondary outcome
Number of subjects with the distinction between amyloidosis and other pigmented diseases in tomograms
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Background: PubMed 22632408Chuang 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.
- Background: PubMed 28083882Lei 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.
- Background: PubMed 25946210Esmat 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.
- Background: PubMed 26984345Al 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.
- Background: PubMed 28300273Chang 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.
- BackgroundChiu 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: PubMed 27420499Wang 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.
- Background: PubMed 26625059Wang 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.
- Background: PubMed 25401013Tsai 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.
- Background: PubMed 24663908Ho 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.
- Background: PubMed 23024905Cheng 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ding-Dar Lee, M.D., Ph. D. principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloidosis, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with clear tissue characteristics of amyloidosis and/or other pigmented diseases in tomograms (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04068077, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.