Optical Coherence TomographyNCT05517889
Repeatability and Stability of Healthy Skin Features on OCT
An observational study of Optical Coherence Tomography and Artificial Intelligence, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
A test-retest study on the stability and repeatability of healthy skin features on OCT Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Optical Coherence Tomography, Artificial Intelligence, Radiomics
- What is being tested?
- Optical coherence tomography
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 31 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 30 healthy volunteers (colleages from the department of dermatology (MUMC+) and precision medicine (UM) will be asked to participate in this study. They must have at least three naevi.
Who may be able to join
- At least18 years of age
Who cannot join
- Unable to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Stability and Repeatability of OCT Features in Healthy Skin: a Test-retest Study
A test-retest study on the stability and repeatability of healthy skin features on OCT
- Being tested
- Optical coherence tomography
- Keywords
- Optical coherence tomography, OCT, Artificial intelligence, AI, Radiomics, Test-retest, Imaging, Dermatology, Skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyDiagnostic test
Optical coherence tomography is a non-invasive scanner which generates real-time in-vivo images of the skin and its adnexal structures. Images are generated by light-interferometry.
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeatable hand-crafted radiomics-features
The number of HRFs that are repeatable in a test-retest setting
Measured: Interval of 10 minutes
Interclass Correlation Coefficient (ICC)
Intraclass Correlation Coefficient (ICC) will be used to assess the correlation and repeatability of the HRFs resulting from OCT scans. ICC will be calculated after all scans have been obtained.
ICC will be used to rank the HRFs. This statistical test is commonly used reliability index in test re-test studies.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence TomographyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University (Precision medicine The D-lab)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517889
- Sponsor's protocol ID
- 2022-3219
- Status last verified
- Feb 2024
- First submitted
- 24 Aug 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Gathered data will only be available to the prinicpal invesitgators and involved research staff (one PhD-candidate from dermatology (MUMC+), one PhD-candidate from precision medicine (UM)).
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Stability and Repeatability of OCT Features in Healthy Skin: a Test-retest Study
- ClinicalTrials.gov ID
- NCT05517889
- Acronym / sponsor ID
- 2022-3219
- Keywords
- Optical coherence tomography, OCT, Artificial intelligence, AI, Radiomics, Test-retest, Imaging, Dermatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University (Precision medicine The D-lab)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Aug 2022 (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.
A test-retest study on the stability and repeatability of healthy skin features on OCT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 healthy volunteers (colleages from the department of dermatology (MUMC+) and precision medicine (UM) will be asked to participate in this study. They must have at least three naevi.
Key inclusion criteria (1 listed)
- At least18 years of age
Key exclusion criteria (1 listed)
- Unable to sign informed consent
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 |
|---|---|---|
| Optical coherence tomographyOptical coherence tomography is a non-invasive scanner which generates real-time in-vivo images of the skin and its adnexal structures. Images are generated by light-interferometry. | Diagnostic test | – |
Primary outcome
Repeatable hand-crafted radiomics-features
Time frame: Interval of 10 minutes
The number of HRFs that are repeatable in a test-retest setting
Interclass Correlation Coefficient (ICC)
Time frame: 1 month
Intraclass Correlation Coefficient (ICC) will be used to assess the correlation and repeatability of the HRFs resulting from OCT scans. ICC will be calculated after all scans have been obtained. ICC will be used to rank the HRFs. This statistical test is commonly used reliability index in test re-test studies.
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 16 Feb 2024.
- Individual participant dataSharing planned: Undecided. Gathered data will only be available to the prinicpal invesitgators and involved research staff (one PhD-candidate from dermatology (MUMC+), one PhD-candidate from precision medicine (UM)).
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Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
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4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
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Anterior Segment Anatomy Assessed by Swept-Source OCT in Ocular Surgery Patients
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Optical Coherence Tomography and Artificial Intelligence, run by Maastricht University Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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 16 Feb 2024. 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 Netherlands. 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?
Repeatable hand-crafted radiomics-features (time frame: Interval of 10 minutes). 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?
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 16 Feb 2024.