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

Colorectal Neoplasms Clinical Trial

— CADx  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05414383
• Other study ID #: 2022.160
• Status: Not yet recruiting
• Start date: December 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Chinese University of Hong Kong
• Contact: Felix Sia
• Phone: 26370428
• Email: felixsia[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 510
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. They have received colonoscopy for screening, surveillance or symptom investigation;

2. They have endoscopic images and videos captured and stored during colonoscopy which are available to be retrieved;

3. They have histologically proven colorectal neoplasia.

4. Written consent obtained

Exclusion Criteria:

1. Poor quality endoscopic images and videos defined as:

1. Incomplete visualization of the colorectal neoplasia due to technical reasons (e.g. out-of-focus, motion-blurred or insufficient illumination);

2. Artifacts due to mucus, air bubbles, stool, or blood.

2. Active gastrointestinal bleeding;

3. Fulminant colitis;

4. Obscured view due to poor bowel preparation;

5. Artificial staining of lesion due to chromoendoscopy.

6. Unable to obtain informed consent

Related Conditions & MeSH terms

• Colorectal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Nanfang Hospital, Southern Medical University, University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy	area under receiver operating characteristic curves, AUROC in prediction of final histopathology	During the colonoscopy
Secondary	Sensitivity	Sensitivity	During the colonoscopy
Secondary	Specificity	Specificity	During the colonoscopy
Secondary	Positive predictive value	Positive predictive value	During the colonoscopy
Secondary	Negative predictive value	Negative predictive value	During the colonoscopy
Secondary	Diagnostic time	Diagnostic time	During the colonoscopy