OCT and Invasion in Cutaneous Skin Lesions
- Conditions
- Cutaneous Squamous Cell CarcinomaKeratosis, ActinicBowen's DiseaseActinic KeratosesDiagnosis
- Interventions
- Diagnostic Test: Optical Coherence TomographyOther: Clinical assessment
- Registration Number
- NCT06014697
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 71
- 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).
- patients who waived informed consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Non-invasive lesion Clinical assessment Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions). Invasive lesion Clinical assessment Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions). Non-invasive lesion Optical Coherence Tomography Lesion with histological confirmation of a actinic keratosis or Bowens disease (non-invasive lesions). Invasive lesion Optical Coherence Tomography Lesion with histological confirmation of a squamous cell carcinoma (invasive lesions).
- Primary Outcome Measures
Name Time Method Sensitivity Through study completion, an average of 6 months Sensitivity of OCT to detect invasion
Specificity Through study completion, an average of 6 months Specificity of OCT in determining the presence/absence of invasion
- Secondary Outcome Measures
Name Time Method Negative predictive value of OCT features 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.
Area under the curve Through study completion, an average of 6 months Area under the curve for OCT in determining the presence/absence of invasion
Specificity of OCT features 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.
Area under the curve for OCT features 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.
Negative predictive value Through study completion, an average of 6 months Negative predictive value of OCT in determining the presence/absence of invasion
Positive predictive value Through study completion, an average of 6 months Positive predictive value of OCT in determining the presence/absence of invasion
Sensitivity of OCT features 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.
Difference OCT and clinical practice 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).
Positive predictive value of OCT features 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.
Trial Locations
- Locations (1)
Maastricht University Medical Center+
🇳🇱Maastricht, Netherlands