Evaluation of CAD-EYE/SCALE-EYE for Detection, Classification, and Measurement of Colorectal Polyps: a Prospective Study
Condition: Colorectal Polyp; Colorectal Adenoma
MeSH terms: Adenoma; Polyps
Study type: Interventional

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.
    

Detailed description: 
      Detailed Description:

      This study will be conducted in several phases: phase 1 will evaluate the feasibility of
      using CAD-eye in real-time practice, training endoscopists to work with this platform,
      obtaining preliminary data on relative size measurement accuracy when using scale eye,
      testing feasibility of fresh polyp specimen size measurement and determining the sample size
      and reference standard for evaluating SCALE-EYE during the subsequent phases of the study in
      randomized controlled trials. Phase 2 will evaluate relative size measurement accuracy of
      SCALE-EYE compared to visual size estimation and CADe/CADx performance in a randomized
      controlled trial. Scale-eye will further be validated through video-based analysis comparing
      different size measurement methods (scale eye, snare, forceps, visual assessment) with
      different groups of endoscopists (experts, staff gastroenterologists, trainees evaluating
      videos showing video sequences that show the polyps either with scale eye, visual or
      instrument information. Furthermore, fresh specimen size measurement and pathology-based size
      (including different ways to prepare specimens for pathology sectioning) will be evaluated
      for agreement between size measurement methods and tissue shrinkage effects. Phase 3 will
      evaluate relative size measurement accuracy of SCALE-EYE compared to snare-based size
      estimation.

      Eligible patients will be adults (aged 45 to 80 years) referred to CHUM for diagnostic,
      screening or surveillance colonoscopy. Patients will undergo colonoscopies using CAD-eye, and
      the size of all polyps detected will be estimated by different subjective and objective
      methods. All polyp size measurements will be videorecorded. Video recordings with different
      measurement instruments (forceps, snare, scale eye, visual assessment) will be assessed with
      different groups of endoscopists (experts, staff gastroenterologists, trainees) for size
      measurements through online video presentations in a randomized order. The main results of
      this study are to evaluate the relative accuracy of SCALE-EYE for polyp size estimation and
      the adenoma detection rates, sensitivity, specificity, NPV for CAD-eye for polyp detection
      and classification. We will also calculate other characteristics of CAD-eye and SCALE-EYE
      tests, the rate of divergence and/or agreement between subjective and objective methods of
      polyp size estimation, the agreement between surveillance intervals based on optical
      diagnosis by CAD-eye and pathological findings, and the false positive rate and latency for
      polyp detection.
    

Intervention name(s): Detection and classification and size measurement of polyp by Artificial Intelligence (Cad eye) and the Scale Eye
Intervention type(s): Diagnostic Test
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: prospective, multi-endoscopist, single center
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Polyps detection; Adenoma detection; Polyps classification