OCT and Invasion in Cutaneous Skin Lesions

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Cutaneous Squamous Cell Carcinoma; Keratosis, Actinic; Diagnosis; Actinic Keratoses; Bowen's Disease

Treatments: Other: Clinical assessment; Diagnostic Test: Optical Coherence Tomography

Study type: Observational

Funder types: Other

Identifiers

NCT06014697

2023-3735

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

71 participants in 2 patient groups

Non-invasive lesion

Description:

Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions).

Treatment:

Diagnostic Test: Optical Coherence Tomography

Other: Clinical assessment

Invasive lesion

Description:

Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).

Treatment:

Diagnostic Test: Optical Coherence Tomography

Other: Clinical assessment