Skip to main content
OpenTrials
Completed

NCT Number: NCT06014697

OCT and Invasion in Cutaneous Skin Lesions

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cutaneous Squamous Cell Carcinoma Actinic Keratoses Bowen's Disease Carcinoma Carcinoma, Squamous Cell Diagnosis Disease Keratosis Keratosis, Actinic Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Pathologic Processes Pathological Conditions, Signs and Symptoms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht University Medical Center+

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical coherence tomography

Diagnostic Test

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

Clinical Assessment

Other

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)

Primary outcomes

  1. Sensitivity

    Time frame: Through study completion, an average of 6 months

    Sensitivity of OCT to detect invasion

  2. Specificity

    Time frame: Through study completion, an average of 6 months

    Specificity of OCT in determining the presence/absence of invasion

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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).

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 28, 2023
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.