跳至主要内容
临床试验/NCT06024629
NCT06024629进行中(未招募)不适用

cOCT Versus LC-OCT for Diagnosing Basal Cell Carcinoma: a Diagnostic Cohort Study

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
197
试验地点
1
主要终点
Diagnostic accuracy of cOCT and LC-OCT

研究概览

简要总结

Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. Equivocal BCC lesions are usually diagnosed by means of a punch biopsy, but since the last few decades, non-invasive imaging techniques for the diagnosis of BCC gained popularity within the field of dermatology. Conventional optical coherence tomography (cOCT) is an example of a non-invasive imaging technique. Recent studies revealed that OCT assessors may achieve high diagnostic certainty and accuracy for diagnosing BCC. However, cOCT has a limited axial and lateral resolution and can therefore only visualize the gross architecture of the skin. It has been proposed that the diagnostic certainty and accuracy of cOCT could be optimized by improving the resolution. Line-field confocal optical coherence tomography (LC-OCT) is a new non-invasive imaging technique that provides tridimensional images of the skin with a cellular resolution. Although the resolution of LC-OCT is superior to cOCT, the penetration depth of LC-OCT (500µm) is limited compared to that of cOCT (1.0-1.5mm). In the proposed study, we aim to assess whether LC-OCT is superior to cOCT in terms of diagnostic accuracy for diagnosing BCC in equivocal BCC lesions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (18+) with equivocal BCC lesions undergoing biopsy conform regular care

排除标准

  • Patients unable to sign informed consent
  • Patients with clinically evident BCC lesions who do not undergo biopsy

结局指标

主要结局

Diagnostic accuracy of cOCT and LC-OCT

时间窗: Measured before september 1st 2024

Diagnostic parameters such as sensitivity, specificity, PPV, NPV and DOR will be evaluated for diagnosing BCC in patients with equivocal lesions and compared between both imaging devices.

次要结局

  • Diagnostic accuracy for BCC subtyping on cOCT and LC-OCT(Measured before september 1st 2024)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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