AI-aided Optical Coherence Tomography for the Detection of Basal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Proportion of high-confidence diagnoses
研究概览
简要总结
Basal cell carcinoma (BCC) is the most common form of cancer among the Caucasian population. A BCC diagnosis is commonly establish by means of an invasive punch biopsy (golden standard). Optical coherence tomography (OCT) is a safe non-invasive diagnostic modality which may replace biopsy if an OCT assessor is able to establish a high confidence BCC diagnosis. Hence, for clinical implementation of OCT, diagnostic certainty should be as high as possible. Artificial intelligence in the form of a clinical decision support system (CDSS) may improve the diagnostic certainty of newly trained OCT assessors by highlighting suspicious areas on OCT scans and by providing diagnostic suggestions (classification). This study will evaluate the effect of a CDSS on the diagnostic certainty and accuracy of OCT assessors.
详细描述
In this diagnostic case control design, OCT assessors will retrospectively evaluate OCT scans of equivocal BCC lesions twice (once with, and once without the help of the CDSS). A total of 124 scans (62 BCC/62 non-BCC) will be included in the study. Cases will be shuffled to prevent recall bias. AI-aided OCT scans and unaided OCT scans will be presented in alternating order. The assessors will express their certainty level on a 5-point confidence scale. The diagnostic certainty and diagnostic accuracy of OCT assessment with CDSS and without CDSS will be compared.
Research questions:
- Does AI-aided OCT assessment result in an increase in high-confidence diagnoses compared to unaided OCT assessment?
- Does AI-aided OCT assessment result in a significant increase in sensitivity for BCC detection without compromising specificity compared to unaided OCT assessment?
- Does AI-aided OCT assessment result in more accurate BCC subtyping compared to unaided OCT assessment (explorative)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Patients (18+ years)
- •Patient underwent OCT scan and punch biopsy for an equivocal BCC lesion
排除标准
- •Patient unable to sign informed consent
结局指标
主要结局
Proportion of high-confidence diagnoses
时间窗: 31-12-2023
The difference in percentage of high-confidence diagnoses will be evaluated between AI-OCT and unaided OCT.
次要结局
- Diagnostic accuracy of high-confidence diagnoses(31-12-2023)
- Diagnostic parameters for BCC subtyping(31-12-2023)