The Value of Optical Coherence Tomography in Discrimination Between the Presence and Absence of Invasion in Clinical Actinic Keratosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Sensitivity
研究概览
简要总结
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.
- Definitely not invasive
- Probably not invasive
- Unknown, probably invasive/probably not invasive
- Probably invasive
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •patients who waived informed consent
结局指标
主要结局
Sensitivity
时间窗: Through study completion, an average of 6 months
Sensitivity of OCT to detect invasion
Specificity
时间窗: Through study completion, an average of 6 months
Specificity of OCT in determining the presence/absence of invasion
次要结局
- Negative predictive value of OCT features(Through study completion, an average of 6 months)
- Area under the curve(Through study completion, an average of 6 months)
- Specificity of OCT features(Through study completion, an average of 6 months)
- Area under the curve for OCT features(Through study completion, an average of 6 months)
- Negative predictive value(Through study completion, an average of 6 months)
- Positive predictive value(Through study completion, an average of 6 months)
- Sensitivity of OCT features(Through study completion, an average of 6 months)
- Difference OCT and clinical practice(Through study completion, an average of 6 months)
- Positive predictive value of OCT features(Through study completion, an average of 6 months)