Repeatability and Stability of Healthy Skin Features on OCT

NCT05517889 | Completed

• 1 other identifier: 2022-3219
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A test-retest study on the stability and repeatability of healthy skin features on OCT

Conditions

Optical Coherence Tomography; Artificial Intelligence; Radiomics

Keywords

Optical coherence tomography; OCT; Artificial intelligence; AI; Radiomics; Test-retest; Imaging; Dermatology; Skin

Outcome Measures

Primary Outcomes (2)

• Repeatable hand-crafted radiomics-features

  The number of HRFs that are repeatable in a test-retest setting

  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.

  1 month

Interventions

Optical coherence tomography DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• At least18 years of age

You may not qualify if:

• Unable to sign informed consent

Sponsors & Collaborators

• Maastricht University Medical Center: lead
• Maastricht University (Precision medicine The D-lab): collaborator

Study Sites (1)

Maastricht UMC+

Maastricht, Limburg, 6229HX, Netherlands

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

NL (1)