Clinical Validation of Polydeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System

Study Overview
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Brief Summary
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This study is a clinical validation of Polydeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. Polydeep Advance 1 is an unicentric prospective diagnostic tests trial with a paired study design. The hypothesis of the study is that Polydeep, a CAD system, is more sensitive than a blinded endoscopists for the detection of colorectal polyps in a high definition colonoscopy.

Detailed Description
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Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC can reduce CRC incidence and mortality. Adenoma detection rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality. Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE international classification has proposed the use of high definition endoscopes that have Narrow Band Imaging. However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary. Computer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, it aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion. Polydeep CAD is a functional prototype. It is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that Polydeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated. The aim of Polydeep advance 1 is to perform the clinical validation within a diagnostic test trial with a paired study design. We will compare the sensitivity of Polydeep to endoscopists blinded to Polydeep in high definition colonoscopy.

Official Title
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Polydeep Advance I: Prospective Diagnostic Tests Trial With a Paired Study Design

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screening program. Surveillance after resection of colorectal adenomas. Acceptance after reading the information sheet and signing the informed consent Exclusion Criteria: Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments). Detected lesions without histologic diagnosis. Previous CRC Previous colonic resection Hereditary CRC syndromes Serrated polyposis syndrome Incomplete colonoscopy without cecal intubation.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: A high definition colonoscopy will be performed by a high experienced endoscopists. The endoscopists will be blinded to a second monitor with the Polydeep evaluation. A second observer will annotate the lesions detected during colonoscopy withdrawal and will inform the endoscopists if Polydeep detects a lesion that is not detected by the endoscopists.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection<br>Both diagnostic interventions will be performed in all patients: High definition colonoscopy and Polydeep system. | Diagnostic Test: Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection<br>* Both diagnostic interventions will be performed in all patients High definition colonoscopy performed by high experienced endoscopists blinded to Polydeep. Polydeep: a CADe and CADx system. The gold standard will be the histological diagnosis of the lesion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of polydeep vs high experienced endoscopist blinded to polydeep | To compare the sensitivity of Polydeep to a high experienced endoscopist for colorectal polyp detection (adenoma or serrated lesion histologically confirmed) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for serrated lesions detection. | To compare the sensitivity of Polydeep to a high experienced endoscopist for serrated lesions detection | 1 year | 
| Sensitivity for adenoma detection. | To compare the sensitivity of Polydeep to a high experienced endoscopist for adenoma detection | 1 year | 
| Sensitivity for advanced colonic lesions | To compare the sensitivity of Polydeep to a high experienced endoscopist for advanced colonic lesions (serrated lesions ≥10mm and/or dysplasia, adenoma ≥10mm and/or villous histology and/or high grade dysplasia) detection | 1 year | 
| Sensitivity for diminute lesions (≤5mm) | To compare the sensitivity of Polydeep to a high experienced endoscopist for diminute lesions (≤5mm) detection | 1 year | 
| To compare the diagnostic yield of the optical diagnosis | To compare diagnostic yield of optic diagnostic of polydeep to high experienced endoscopists. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal adenomas, Colorectal polyps, Serrated lesions, Computer-Aided detection System (CAD)