Impact of Artificial Intelligence (AI) on Adenoma Detection During Colonoscopy in FIT+ Patients. (AIFIT)

March 24, 2024 updated by: Franco Radaelli, Valduce Hospital

Impact of AI (Artificial Intelligence) on Adenoma Detection During Colonoscopy in FIT+ Patients: a Prospective Randomized Controlled Trial

The Italian screening program invites the resident population aged 50-74 for Fecal Immunochemical Test (FIT) every 2 years. Subjects who test positive are referred for colonoscopy. Maximizing adenoma detection during colonoscopy is of paramount importance in the framework of an organized screening program, in which colonoscopy represent the key examination. Initial studies consistently show that Artificial iIntelligence-based systems support the endoscopist in evaluating colonoscopy images potentially increasing the identification of colonic polyps. However, the studies on AI and polyp detection performed so far are mostly focused on technical issues, are based on still images analysis or recorded video segments and includes patients with different indications for colonoscopy. At the best of our knowledge, data on the impact on AI system in adenoma detection in a FIT-based screening program are lacking. The present prospective randomized controlled trial is aimed at evaluating whether the use of an AI system increases the ADR (per patient analysis) and/or the mean number of adenomas per colonoscopy in FIT-positive subjects undergoing screening colonoscopy. Therefore Patients fulfilling the inclusion criteria are randomized (1:1) in two arms: A) patients receive standard colonoscopy (with high definition-HD endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination; B) patients receive colonoscopy examinations (with HD endoscopes) equipped with an AI system (in both insertion and withdrawal phase); all polyps identified are removed and sent for histopathology examination. In the present study histopathology represents the reference standard.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • Italy
      • Como, Italy, 22100
        • Gastroenterology Unit, Valduce 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Consecutive adult (50-74 yrs.) outpatients undergoing colonoscopy in the frame of the FIT-based screening program.

Exclusion Criteria:

  • patients with CRC history or hereditary polyposis syndromes or hereditary non-polyposis colorectal cancer
  • patients with inadequate bowel preparation
  • patients in which cecal intubation was not achieved or scheduled for partial examinations
  • patients with gastrointestinal symptoms
  • polyps could not be resected due to ongoing anticoagulation preventing resection and pathological assessment

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

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard WL (white light) colonoscopy
all patients receive standard colonoscopy (with high definition- HD- endoscopes) with white light (WL) in both insertion and withdrawal phase; all polyps identified are removed and sent for histopathology examination.
Experimental: Standard colonoscopy with assistance of Artificial Intelligence (CAD-EYE (Fujifilm Co, Tokyo, Japan)
all patients receive colonoscopy examinations (with HD endoscopes) equipped with an Ai system (CAD-EYE, Fujifilm Co, Tokyo, Japan) in both insertion and withdrawal phase). This system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected.All polyps identified are removed and sent for histopathology examination.
Device: Artificial Intelligence System (CAD EYE, Fujifilm Co.)
A dedicated CNN-based AI system (CAD EYE, Fujifilm Co, Tokyo, Japan) has been recently developed. The Computer-aided diagnosis (CAD) CAD EYE system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ADR
Time Frame: 10 months
Adenoma Detection Rate: rate of participants with at least on adenoma detected during colonoscopy
10 months
APC
Time Frame: 10 months
Adenoma per Colonoscopy: it is determined by dividing the total number of adenomas removed by the total number of colonoscopies performed
10 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adv-ADR
Time Frame: 10 months
Adv-ADR: rate of participants with at least on advanced adenoma detected during colonoscopy
10 months
SSL-DR:
Time Frame: 10 months
SSL-ADR: the serrated lesions with neoplastic potential (sessile serrated lesions-SSA; traditional serrated adenomas - TSA) detection rate.
10 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of Ai on endoscopist with different ADR
Time Frame: 10 months
The variation in ADR will be stratified according the initial ADR of endoscopists participating in the present study
10 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Valduce Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 31, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 598/2020

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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