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Real-World Validation of an Artificial Intelligence Characterization Support (CADx) System

NCT05034185 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 450

Last updated 2023-02-22

No results posted yet for this study

Summary

Colorectal cancer (CRC) is a leading cause of cancer-related morbidity and mortality worldwide, with rates of CRC predicted to increase. Colonoscopy is currently the gold standard of screening for CRC. Artificial intelligence (AI) is seen as a solution to bridge this gap in adenoma detection, which is a quality indicator in colonoscopy. AI systems utilize deep neural networks to enable computer-aided detection (CADe) and computer-aided classification (CADx). CADe is concerned with the detection of polyps during colonoscopy, which in turn is postulated to help decrease the adenoma miss-rate.

In contrast, CADx deals with the interpretation of polyp appearance during colonoscopy to determine the predicted histology. Prediction of polyp histology is crucial in helping Clinicians decide on a "resect and discard" or "diagnose and leave strategy". It is also useful for the Clinician to be aware of the predicted histology of a colorectal polyp in determining the appropriate method of resection in terms of safety and efficacy. While CADe has been studied extensively in randomized controlled trials, there is a lack of prospective data validating the use of CADx in a clinical setting to predict polyp histology.

The investigators plan to conduct a prospective, multi-centre clinical trial to validate the accuracy of CADx support for prediction of polyp histology in real-time colonoscopy.

Conditions

  • Colonic Polyp
  • Colonic Neoplasms
  • Colonic Dysplasia

Interventions

DEVICE

Computer-aided diagnosis (CADx) support tool

The CADx support tool operates when the Clinician switches the preconfigured CAD EYE function on using a button on the controller while the scope system is in BLI mode. This is performed after the Clinician first makes an optical prediction of polyp histology using IEE as described. The CADx support tool will make a prediction of polyp histology as "hyperplastic" or "neoplastic".

Sponsors & Collaborators

  • National University Hospital, Singapore

    collaborator OTHER

  • Singapore General Hospital

    collaborator OTHER

  • Tan Tock Seng Hospital

    collaborator OTHER

  • Changi General Hospital

    lead OTHER

Principal Investigators

  • Dr James Li · Changi General Hospital, Singapore Health Services

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-03
Primary Completion
2022-07-31
Completion
2022-10-01

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05034185 on ClinicalTrials.gov