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

February 21, 2023 updated by: James Li Weiquan, Changi General Hospital

Real-World Validation of an Artificial Intelligence Characterization Support (CADx) System for Prediction of Polyp Histology in Colonoscopy: A Prospective Multicentre Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Colonoscopy is currently the gold standard of screening for CRC. A 1% increase in adenoma detection rate (ADR) estimated to be associated with a 3% decreased risk of interval CRC. AI systems can be broadly divided into CADe (for detection) and CADx (for diagnosis, or prediction of polyp histology in the context of colonoscopy). CADe has been extensively studied, with several randomized controlled trials and meta-analysis showing a higher ADR when CADe is used compared to the control groups without CADe.

Besides the ADR, predicted polyp histology is a key component in the performance of colonoscopy as this enables the Clinician to make a decision regarding its management, as described above. In this regards, image-enhanced endoscopy (IEE) is often used to help Clinicians determine if colorectal polyps found on colonoscopy are neoplastic or hyperplastic. The most commonly used non-magnification classification is the NBI International Colorectal Endoscopic (NICE), while the Japan NBI Expert Team (JNET) classification is used where endoscopy systems with optical magnification and the proper training is available. However, these classification systems have varying diagnostic accuracy and interobserver agreement. Previous prospective studies looking at CADx have utilized endocytoscopy and autofluorescence imaging (CAD-AFI) with positive results. However, the major limitation in these CADx studies is that these imaging systems are costly and are not readily available in most centres worldwide. Furthermore, most Clinicians performing colonoscopies have not been trained in these modalities of imaging and will have to rely completely on the CADx function to detect polyps if these imaging modalities are used, without being able to fall back on their experience and training should there be doubts about the accuracy of a CADx diagnosis in a real-world setting.

The Fujifilm 7000 System (Fujifilm Corp., Tokyo) has been in routine clinical use in all tertiary institutions in Singapore. The CAD EYE system was developed by Fujifilm Corp to aid Clinicians in colonoscopy with CADe and CADx functions. The basic functions and handling of the colonoscope, as well as the endoscopy processing unit, are similar to what is currently available in clinical practice, with the added CAD EYE software. The controller has been configured to allow the operator to activate and deactivate the CAD function depending on the need for it. These functions can be turned on and off using a button on the controller by the Clinician. The CADe and CADx functions operate when white light and blue laser imaging (BLI) are used, respectively. This provides a unique opportunity to externally validate the use of the CADx support tool by evaluating its diagnostic accuracy with final polyp histology as the gold standard, while also comparing its performance in a clinical setting against a Clinician using IEE (which is the conventional method of predicting polyp histology in colonoscopy).

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.

Study Type

Observational

Enrollment (Actual)

450

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital, National University Hospital, Singapore General Hospital and Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients age 40 years and above and who have indications for colonoscopy will be eligible for the study. The patients who have been identified as eligible for the study will be counselled on the details, risks and benefits prior to the performance of colonoscopy. This counselling may take place in the outpatient or inpatient setting.

Patients with one or more polyps detected during colonoscopy will be included in the study. The rest of the inclusion and exclusion criteria are as described.

Description

Inclusion Criteria:

  1. Patients who have an indication for colonoscopy and who have at least one polyp detected during colonoscopy
  2. 40 years of age and above
  3. Consent obtained for the study

Exclusion Criteria:

  1. Less than 39 years of age
  2. Declined participation in study
  3. Patients with no polyps detected during colonoscopy
  4. Patients with inflammatory bowel disease
  5. Patients with known unresected colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with one or more polyps detected

During colonoscopy, the Clinician inspect for the presence of polyps as per routine clinical practice with the CAD EYE function turned off. When a polyp is encountered, the Clinician will make a prediction on the histology based on the white light and BLI features of the polyp with and without optical magnification, as per routine clinical practice. Following this, the CAD EYE function will be switched on and the Clinician will take note of the CADx prediction for the same polyp, which will be either "neoplastic" or "hyperplastic".

In addition, other polyp features such as the size and location will be recorded, which is similar to what is performed in routine clinical practice. The polyp will be resected and sent for pathological examination, which will form the "gold standard" for the diagnosis of polyp histology.
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".

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the diagnostic performance of the CADx support tool compared to optical prediction of polyp histology by the Clinician in real-time colonoscopy in a clinical setting
Time Frame: 1 year
Polyp histology used as gold standard
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the diagnostic performance of CADx versus optical prediction of polyp histology by endoscopist in the subgroup analysis
Time Frame: 1 year
Subgroups include bowel preparation, size of polyp and location
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Collaborators

National University Hospital, Singapore
Singapore General Hospital
Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

July 31, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

September 2, 2021

First Submitted That Met QC Criteria

September 2, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIRB Ref: 2021/2001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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