NCT05414383

A Prospective Study to Evaluate the Diagnostic Accuracy of Computer-aided Diagnosis (CADx) System in Real-time Characterization of Colorectal Neoplasia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 510 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators hypothesize that a newly developed CADx system will have a higher diagnostic accuracy in predicting histopathology of colorectal neoplasia than both expert and junior endoscopists.

Detailed description

Accurate diagnosis and characterization of colorectal polyps is essential before endoscopic resection. Optical diagnosis by enhanced imaging modality (e.g. Narrow Band Imaging, NBI) allows real-time prediction of histopathology. It can assist endoscopists to select the appropriate technique and differentiate between neoplastic or non-neoplastic polyps. Nevertheless, due to the substantial inter-observer variability, the widespread use was limited. Recently, artificial intelligence and computer-aided polyp diagnosis (CADx) systems have evolved rapidly. The major limitation was the heterogeneity from different types of imaging modalities. Endocytoscopic images require extra steps for pre-staining and magnification, which are time consuming and operator dependent. As a result, it limits the generalisability and applicability in real-world settings. A novel CADx system will be developed for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy (NBI). The diagnostic accuracy of this CADx system will be compared with both expert and junior endoscopists.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	CADx	A novel CADx system for real-time histopathological prediction of colorectal neoplasia, by using non-magnified conventional white-light and image enhanced endoscopy.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2025-12-31
• First posted: 2022-06-10
• Last updated: 2024-02-09