Optical-Coherence Tomography for the Non-invasive Diagnosis and Subtyping of Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 入组人数
- 963
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of OCT in diagnosis and subtyping of BCC
研究概览
简要总结
Rationale:
To date, the diagnosis and subtyping of basal cell carcinoma (BCC) is verified with histopathology which requires a biopsy. Because this technique is invasive, new non-invasive strategies have been developed, including Optical Coherence Tomography (OCT). This innovative technique enables microscopically detailed examination of lesions, which is useful for diagnosing and identification of various subtypes of BCC. The diagnostic value of the VIVOSIGHT OCT in daily clinical practice, has not been established to date.
详细描述
Objective:
The aim of the study is to investigate the diagnostic value and usability of OCT in the diagnosis and subtyping of clinically suspect BCC.
Study design:
In this prospective observational trial, the VIVOSIGHT OCT device will be used on all patients attending the policlinic Dermatology of the MUMC and will undergo a skin biopsy. Information collected from OCT images will be compared with the clinical diagnosis by the specialist, including dermatoscopy, and the gold standard consisting of the histopathological diagnosis obtained from biopsy.
Study population:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or older) receiving a skin biopsy of a lesion clinically suspected for a non-melanoma skin cancer or premalignancy
排除标准
- •Patients who were incompetent to sign informed consent were excluded
结局指标
主要结局
Diagnostic accuracy of OCT in diagnosis and subtyping of BCC
时间窗: February 2017-April 2021
The main study parameter is the diagnostic value of OCT in diagnosis BCC defined as accuracy, sensitivity, specificity and negative- and positive diagnostic values. An increase of at least 10 percent in specificity and an equal sensitivity of OCT-based diagnosis is expected, compared with the clinical diagnosis and the golden-standard histopathology.
次要结局
- Developing a deep learning algorithm for automated detection of basal cell carcinoma (BCC) and recognizing three different BCC subtypes in OCT images.(June 2020-August 2021)