Real Time Computer-aided Diagnosis (CADx) of Diminutive Colorectal Polyps Using Artificial Intelligence
试验速览
- 阶段
- 不适用
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- The negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
研究概览
简要总结
Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Artificial intelligence has great potential in image analysis in gastrointestinal endoscopy. Aim of this study is to investigate the real-time diagnostic performance of AI4CRP for the classification of diminutive colorectal polyps, and to compare it with the real-time diagnostic performance of commercially available CADx systems.
详细描述
Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Despite additional training, even experienced endoscopists continue to fail meeting international thresholds set for safe implementation of treatment strategies based on optical diagnosis.
Multiple machine learning techniques - computer-aided diagnosis (CADx) systems - have been developed for applications in medical imaging within colonoscopy and can improve endoscopic classification of colorectal polyps.
Aim of this study is to explore the feasibility of the workflow using AI4CRP (a CNN based CADx system) real-time in the endoscopy suite, and to investigate the real-time diagnostic performance of AI4CRP for the diagnosis of diminutive (<5mm) colorectal polyps. Secondary, the real-time performance of commercially available CADx systems will be investigated and compared with AI4CRP performance.
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
- •Age >18 years;
- •Patients with at least one colorectal polyps encountered during colonoscopy;
- •Patients referred for a colonoscopy by the Dutch bowel cancer screening program, patients undergoing a colonoscopy for endoscopic surveillance, or patients undergoing a colonoscopy because of complaints;
- •Written informed consent.
排除标准
- •Patients with prior history of inflammatory bowel diseases (IBD) or polyposis syndromes;
- •Patients with inadequate bowel preparations after adequate washing, suctioning, and cleaning manoeuvres have been performed by the endoscopist;
- •Patients undergoing an emergency colonoscopy;
- •Written objection in the patient file for participation in scientific research.
结局指标
主要结局
The negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
时间窗: 1 year
The real-time negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
Technical feasibility of real-time use of AI4CRP.
时间窗: 6 months
The technical feasibility of real-time use of AI4CRP in the endoscopy suite regarding a proper reception of the video output from the local endoscopy processor towards AI4CRP (in high definition quality, without any delays in time).
The specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
时间窗: 1 year
The real-time specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
User interface feasibility of real-time use of AI4CRP.
时间窗: 6 months
The user interface feasibility of real-time use of AI4CRP in the endoscopy suite regarding a correct alignment of the user interface of AI4CRP with the video output from the local endoscopy system (resizing image pixels and anonymization).
The diagnostic accuracy of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
时间窗: 1 year
The real-time diagnostic accuracy of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). Diagnostic accuracy defined as the percentage of correctly optically diagnosed colorectal polyps.
The sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
时间窗: 1 year
The real-time sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
The Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
时间窗: 1 year
The real-time Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
The positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
时间窗: 1 year
The real-time positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan).
次要结局
- The sensitivity of AI4CRP per polyp.(1 year)
- The sensitivity of CAD EYE in BLI mode, per polyp.(1 year)
- The localization score of AI4CRP.(1 year)
- The diagnostic accuracy of CAD EYE in BLI mode, per polyp.(1 year)
- The negative predictive value of CAD EYE in BLI mode, per polyp.(1 year)
- The specificity of AI4CRP per polyp.(1 year)
- The Area Under ROC Curve (AUC) of CAD EYE in BLI mode, per polyp.(1 year)
- The difference in diagnostic accuracy of endoscopists per polyp before and after AI.(1 year)
- The difference in sensitivity of endoscopists per polyp before and after AI.(1 year)
- The diagnostic accuracy of AI4CRP per polyp.(1 year)
- The positive predictive value of AI4CRP per polyp.(1 year)
- The Area Under ROC Curve (AUC) of AI4CRP per polyp.(1 year)
- The diagnostic accuracy of AI4CRP per patient.(1 year)
- The diagnostic accuracy of CAD EYE per patient.(1 year)
- The difference in specificity of endoscopists per polyp before and after AI.(1 year)
- The negative predictive value of AI4CRP per polyp.(1 year)
- The specificity of CAD EYE in BLI mode, per polyp.(1 year)
- The positive predictive value of CAD EYE in BLI mode, per polyp.(1 year)
- The difference in positive predictive value of endoscopists per polyp before and after AI.(1 year)
- The agreement in surveillance interval based on optical diagnosis and histopathology.(1 year)
- The difference in negative predictive value of endoscopists per polyp before and after AI.(1 year)