OCT and Invasion in Cutaneous Skin Lesions

October 18, 2023 updated by: Maastricht University Medical Center

The Value of Optical Coherence Tomography in Discrimination Between the Presence and Absence of Invasion in Clinical Actinic Keratosis

The increasing incidence of actinic keratosis (AK), morbus Bowen (MB) and cutaneous squamous cell carcinoma (cSCC), the patients with often multiple lesions and the disadvantages of invasive diagnostics show the need for an accurate non-invasive diagnostic tool for the determination of invasive growth in AK and MB.

Optical coherence tomography (OCT) is a non-invasive scanner creating cross-sectional images of the skin, to a depth of 1-1,5 mm based on light waves. Until now, OCT has been proposed as non-invasive diagnostic tool for basal cell carcinomas. Although the diagnostic value of OCT for detection and sub-typing of basal cell carcinomas has already been demonstrated, it is unclear whether OCT can discriminate between invasive and non-invasive lesions (AK, MB and cSCCs). There are some studies that describe OCT characteristics of AK, MB and cSCCs, however, these characteristics have a lot of overlap (8-13). To date there are no clearly distinctive OCT features to distinguish between AK, MB and cSCCs. This study aims to investigate the value of OCT in discriminating between the presence and absence of invasion in lesions with clinical suspicion for invasion.

Two experienced OCT-assessors will evaluate the OCT scans independently. The OCT assessors are blinded to the histological diagnosis of the lesions (invasive or non-invasive), which is used as golden standard.

A 5-point Likert scale is used for OCT assessment.

  1. Definitely not invasive
  2. Probably not invasive
  3. Unknown, probably invasive/probably not invasive
  4. Probably invasive
  5. Definitely invasive

In addition to completing the Likert-scale, assessors are asked to describe the presence/absence of predefined OCT characteristics (a.o. hyperkeratosis and the presence of the dermo-epidermal junction)

In case of disagreement between the independent assessors, the OCT scan will be re-assessed in a consensus meeting.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Maastricht, Netherlands
        • Maastricht University Medical Center+

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with a histologically confirmed actinic keratosis, bowens disease or cutaneous squamous cell carcinoma, with a clinical differential diagnosis of actinic keratosis and/or bowens disease and cutaneous squamous cell carcinoma, included in a previous study. All patients retrospectively had a OCT scan.

Description

Inclusion Criteria:

  • Patients who are included in a previous study on OCT, with written informed consent to use their data regarding OCT.
  • Patients who retrospectively had an OCT scan for their skin lesion
  • With a histological confirmed actinic keratosis, bowens disease or cutaneous squamous cell carcinoma of the skin
  • with a differential diagnosis of a invasive lesion (cutaneous squamous cell carcinoma) and a non-invasive lesion (bowens disease or actinic keratosis).

Exclusion Criteria:

  • patients who waived informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non-invasive lesion
Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions).
Diagnostic test: Optical Coherence Tomography
Assessment of the lesion with a non-invasive OCT scan according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)
Other Names:
  • OCT
Other: Clinical assessment
Clinical assessment of the lesion by a dermatologist according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)
Invasive lesion
Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).
Diagnostic test: Optical Coherence Tomography
Assessment of the lesion with a non-invasive OCT scan according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)
Other Names:
  • OCT
Other: Clinical assessment
Clinical assessment of the lesion by a dermatologist according to a confidence scale (5-point Likert scale: 1 Definitely not invasive, 2 Probably not invasive, 3 Unknown invasive or non-invasive, 4 Probably invasive, 5 Definitely invasive)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: Through study completion, an average of 6 months
Sensitivity of OCT to detect invasion
Through study completion, an average of 6 months
Specificity
Time Frame: Through study completion, an average of 6 months
Specificity of OCT in determining the presence/absence of invasion
Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Negative predictive value
Time Frame: Through study completion, an average of 6 months
Negative predictive value of OCT in determining the presence/absence of invasion
Through study completion, an average of 6 months
Positive predictive value
Time Frame: Through study completion, an average of 6 months
Positive predictive value of OCT in determining the presence/absence of invasion
Through study completion, an average of 6 months
Area under the curve
Time Frame: Through study completion, an average of 6 months
Area under the curve for OCT in determining the presence/absence of invasion
Through study completion, an average of 6 months
Sensitivity of OCT features
Time Frame: Through study completion, an average of 6 months
Sensitivity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
Through study completion, an average of 6 months
Difference OCT and clinical practice
Time Frame: Through study completion, an average of 6 months
Difference in diagnostic parameters (sensitivity, specificity and area under the curve) between OCT and clinical practice (clinical assessment).
Through study completion, an average of 6 months
Specificity of OCT features
Time Frame: Through study completion, an average of 6 months
Specificity for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
Through study completion, an average of 6 months
Positive predictive value of OCT features
Time Frame: Through study completion, an average of 6 months
Positive predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
Through study completion, an average of 6 months
Negative predictive value of OCT features
Time Frame: Through study completion, an average of 6 months
Negative predictive value for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
Through study completion, an average of 6 months
Area under the curve for OCT features
Time Frame: Through study completion, an average of 6 months
Area under the curve for specific OCT-features characteristic for the presence/absence of invasion, such as presence/absence of the dermo-epidermal junction or presence/absence of hyperkeratosis.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: K Mosterd, MD, PhD, Maastricht University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

August 15, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-3735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Keratosis, Actinic

Clinical Trials on Optical Coherence Tomography

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe