Colorectal Neoplasms Clinical Trial
— COMET-OPTICALOfficial title:
Real Time Computer-aided Diagnosis (CADx) of Diminutive Colorectal Polyps Using Artificial Intelligence
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.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | December 2022 |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Catharina Ziekenhuis Eindhoven | Eindhoven | Noord-Brabant |
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Catharina Ziekenhuis Eindhoven, Eindhoven University of Technology |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Technical feasibility of real-time use of AI4CRP. | 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). | 6 months | |
Primary | User interface feasibility of real-time use of AI4CRP. | 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). | 6 months | |
Primary | The diagnostic accuracy of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | 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. | 1 year | |
Primary | The sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | The real-time sensitivity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | 1 year | |
Primary | The specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | The real-time specificity of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | 1 year | |
Primary | The negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | The real-time negative predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | 1 year | |
Primary | The positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | The real-time positive predictive value of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | 1 year | |
Primary | The Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | The real-time Area Under ROC Curve (AUC) of AI4CRP per image modality (HDWL, BLI, LCI, i-scan). | 1 year | |
Secondary | The diagnostic accuracy of AI4CRP per polyp. | The real-time diagnostic accuracy of AI4CRP per polyp (comprising the combination of different imaging modalities). | 1 year | |
Secondary | The sensitivity of AI4CRP per polyp. | The real-time sensitivity of AI4CRP per polyp (comprising the combination of different imaging modalities). | 1 year | |
Secondary | The specificity of AI4CRP per polyp. | The real-time specificity of AI4CRP per polyp (comprising the combination of different imaging modalities). | 1 year | |
Secondary | The negative predictive value of AI4CRP per polyp. | The real-time negative predictive value of AI4CRP per polyp (comprising the combination of different imaging modalities). | 1 year | |
Secondary | The positive predictive value of AI4CRP per polyp. | The real-time positive predictive value of AI4CRP per polyp (comprising the combination of different imaging modalities). | 1 year | |
Secondary | The Area Under ROC Curve (AUC) of AI4CRP per polyp. | The real-time Area Under ROC Curve (AUC) of AI4CRP per polyp (comprising the combination of different imaging modalities). | 1 year | |
Secondary | The diagnostic accuracy of CAD EYE in BLI mode, per polyp. | The real-time diagnostic accuracy of CAD EYE in BLI mode, per polyp. | 1 year | |
Secondary | The sensitivity of CAD EYE in BLI mode, per polyp. | The real-time sensitivity of CAD EYE in BLI mode, per polyp. | 1 year | |
Secondary | The specificity of CAD EYE in BLI mode, per polyp. | The real-time specificity of CAD EYE in BLI mode, per polyp. | 1 year | |
Secondary | The negative predictive value of CAD EYE in BLI mode, per polyp. | The real-time negative predictive value of CAD EYE in BLI mode, per polyp. | 1 year | |
Secondary | The positive predictive value of CAD EYE in BLI mode, per polyp. | The real-time positive predictive value of CAD EYE in BLI mode, per polyp. | 1 year | |
Secondary | The Area Under ROC Curve (AUC) of CAD EYE in BLI mode, per polyp. | The real-time Area Under ROC Curve (AUC) of CAD EYE in BLI mode, per polyp. | 1 year | |
Secondary | The diagnostic accuracy of AI4CRP per patient. | The real-time diagnostic accuracy of AI4CRP per patient (in case of multiple polyps per patient). | 1 year | |
Secondary | The diagnostic accuracy of CAD EYE per patient. | The real-time diagnostic accuracy of CAD EYE per patient (in case of multiple polyps per patient). | 1 year | |
Secondary | The localization score of AI4CRP. | The localization score of AI4CRP regarding the number of images in which the heatmap produced by AI4CRP pointed out the area of interest (scale: correct, incorrect, or partly correct area of interest). | 1 year | |
Secondary | The difference in diagnostic accuracy of endoscopists per polyp before and after AI. | The difference in real-time diagnostic accuracy of endoscopists per polyp before and after AI. | 1 year | |
Secondary | The difference in sensitivity of endoscopists per polyp before and after AI. | The difference in real-time sensitivity of endoscopists per polyp before and after AI. | 1 year | |
Secondary | The difference in specificity of endoscopists per polyp before and after AI. | The difference in real-time specificity of endoscopists per polyp before and after AI. | 1 year | |
Secondary | The difference in negative predictive value of endoscopists per polyp before and after AI. | The difference in real-time negative predictive value of endoscopists per polyp before and after AI. | 1 year | |
Secondary | The difference in positive predictive value of endoscopists per polyp before and after AI. | The difference in real-time positive predictive value of endoscopists per polyp before and after AI. | 1 year | |
Secondary | The agreement in surveillance interval based on optical diagnosis and histopathology. | The agreement in surveillance interval based on optical diagnosis of diminutive colorectal polyps and histopathology of small and large colorectal polyps, compared to the surveillance interval based on histopathology of all colorectal polyps (diminutive, small, and large). | 1 year |
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