Evaluation of CAD-EYE/SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study

NCT05236790 | Completed

• 1 other identifier: 21.305
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the clinical implementation of an AI system is an optimal tool to monitor, audit and improve the detection and classification of polyps during colonoscopy. The purpose of this prospective clinical cohort study is to evaluate the performance of the SCALE-EYE virtual scale for measuring polyp size when used during live colonoscopies. The investigators also wish to evaluate CAD-eye for detection and classification of polyp histology. It is hypothesized that CAD-eye and SCALE-EYE can function in real-time practice with high accuracy.

Conditions

Colorectal Polyp; Colorectal Adenoma

Keywords

Polyps detection; Adenoma detection; Polyps classification

Outcome Measures

Primary Outcomes (3)

• Evaluation of the Scale-Eye

  to compare the relative accuracies of SCALE-EYE size measurement, visual size estimation or size estimation based on a standard polypectomy snare for colorectal polyps during real-time colonoscopies with measurement of viable specimens by a Vernier caliper as reference standard. Relative accuracy is defined as "1-\[(ScaleEye measurement - gold standard measurement)/gold standard measurement\] x100". Scale: 0-100. Higher score is a better outcome.

  30 days

• Evaluation of CADe function

  compare the adenoma detection rate between the CAD-eye-assisted colonoscopy and standard colonoscopy (i.e., detecting adenomas only by endoscopists)

  30 days

• Evaluation of CADx function

  evaluate the accuracy, sensitivity, specificity, positive and negative predictive value of CADx for classifying 1-5 mm polyp histology into neoplastic and non-neoplastic compared with the histopathology outcomes as the reference standard

  30 days

Secondary Outcomes (9)

• Agreement and discrepancy between SCALE-EYE and other measurement

  30 days

• Video-based assessments

  30 days

• CADe sensitivity in polyp detection

  30 days

• CADe function: proportion of polyps detected

  30 days

• Evaluation of CADx function

  Through study completion, estimation: 3 months

Study Arms (2)

Artificial intelligence for real-time detection and monitoring of colorectal polyps

EXPERIMENTAL

Colonoscopies will be performed according to the standard of care. Patients will undergo colonoscopies using CAD-eye (CADe and CADx) and Scale-eye. All optically diagnosed (CADx) polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. CADx will be combined with human input for final diagnosis.

Diagnostic Test: Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye

Real time polyp detection using a standard colonoscopy without CAD eye

NO INTERVENTION

Real time polyp detection using a standard colonoscopy without CAD eye and without CADe. Patients will undergo a standard colonoscopy. Polyp size measurement will be assessed visually (phase 1 and 2) or with instruments such as snare or forceps (phase 3 or later) and polyp classification will be done by CADx without further input by the endoscopist. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards.

Interventions

Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye DIAGNOSTIC_TEST

Detection and classification and size measurement of polyp by Artificial Intelligence (CADeye) and Scale Eye This study will be conducted in multiple phases: phase 1 (pilot phase, n=40 polyps, about 60 patients) to evaluate the feasibility of applying Scale Eye in real-time practice, training endoscopists to work with CADe and CADx and determining the sample size and reference standard to evaluate SCALE-EYE during the second phase of the study (randomized controlled trial), phase 2 will evaluate the performance of SCALE-EYE and CAD-eye in real-time practice. The sample size for phase 2 (RCT comparing visual with scasle eye) will be based on the pilot data allowing to compare relative accuracy of size measurement with scale eye versus visual size estimation. After completion of phase 2 later phases will use instruments such as snare and/or forceps as reference measurement devices compared to relative accuracy of measurement when using scale eye.

Artificial intelligence for real-time detection and monitoring of colorectal polyps

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication of undergoing a screening, surveillance, or diagnostic colonoscopy
• Age 45-80 years
• Signed informed consent

You may not qualify if:

• Known inflammatory bowel disease (IBD)
• Active Colitis
• Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class \>3
• Coagulopathy
• Familial polyposis syndrome
• Emergency colonoscopies
• Poor bowel preparation score defined as the total Boston bowel preparation score \<6 and the right-segment score \<2.
• For per-polyp analysis:
• For optical diagnosis (CADx) we will exclude all polyps \>5mm. We will also exclude sessile serrated polyps and traditional serrated adenomas from the analysis as CADx can only differentiate between adenomas and hyperplastic polyps.
• For polyp size measurement (SCALE-EYE), we will exclude all polyps resected in several pieces (piecemeal resection), or specimens damaged (e.g., fractured) during the suction and retrieval process, submillimeter polyps too small for measurement after resection. Polyps after the 5th resected polyp in a single piece will be excluded to reduce the time associated with the procedure.
• For polyp detection (CADe) we will not exclude any polyp from the analysis.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier Universitaire de Montréal

Montreal, Quebec, Canada

Location

Related Publications (2)

• Djinbachian R, Haumesser C, Taghiakbari M, Pohl H, Barkun A, Sidani S, Liu Chen Kiow J, Panzini B, Bouchard S, Deslandres E, Alj A, von Renteln D. Autonomous Artificial Intelligence vs Artificial Intelligence-Assisted Human Optical Diagnosis of Colorectal Polyps: A Randomized Controlled Trial. Gastroenterology. 2024 Jul;167(2):392-399.e2. doi: 10.1053/j.gastro.2024.01.044. Epub 2024 Feb 7.

  PMID: 38331204 DERIVED

• Taghiakbari M, Djinbachian R, Haumesser C, Sidani S, Chen Kiow JL, Panzini B, von Renteln D. Measuring Size of Colorectal Polyps Using a Virtual Scale Endoscope or Visual Assessment: A Randomized Controlled Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1309-1317. doi: 10.14309/ajg.0000000000002623. Epub 2023 Dec 12.

  PMID: 38084850 DERIVED

Study Officials

• Daniel von Renteln

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The randomization would be concealed. The patient will be blind to the allocated groups. The endoscopist will be blind to the allocated groups until the beginning of the procedure. The pathologists will be blinded to the polyp size measurements by the endoscopists, the SCALE-EYE, or other methods.
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective, multi-endoscopist, single center

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: June 20, 2022
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)