Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 2.

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 2 is a multicentric randomized clinical trial with a tandem colonoscopy design. The hypothesis of this study is that Polydeep assisted colonoscopy will reduce the number of missed adenomas in the first withdrawal.

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 (NBI International Colorectal Endoscopic) 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 This clinical trial is part of the clinical validation of PolyDeep. We will perform a randomized clinical trial with a tandem colonoscopy design with adenoma miss rate as the main objective.

Official Title
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PolyDeep Advance 2: Clinical Validation of PolyDeep. Randomized Clinical Trial With a Tandem Colonoscopy Design.

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Diagnostic Test: Standard technique First colonoscopy without PolyDeep
* Diagnostic Test: Combination technique First colonoscopy with PolyDeep


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 colorectal adenomas resection. Authorization after reading the information sheet and singing the informed consent. Exclusion Criteria: Incomplete colonoscopy without cecal intubation. Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments). Detected lesions without histological diagnosis. Previous CRC. Previous colonic resection. CRC associated hereditary syndrome. Serrated polyposis syndrome.

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
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Patients who fulfill criteria will be randomly allocated to perform the first withdrawal with the standard technique versus PolyDeep assisted colonoscopy. All colorectal detected polyps will be resected. After a second cecal intubation, second withdrawal will be performed with the opposite technique
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Technique followed by Combination<br>Back-to-back tandem colonoscopies by the same endoscopist. The first colonoscopy will be performed without PolyDeep (standard technique) followed immediately by another colonoscopy with PolyDeep (combination technique). | Diagnostic Test: Standard technique First colonoscopy without PolyDeep<br>* Standard technique First colonoscopy without PolyDeep<br>|
| Active Comparator: Combination followed by Standard Technique<br>Back-to-back tandem colonoscopies by the same endoscopist. In this arm, the first colonoscopy with be performed with PolyDeep (combination technique) followed immediately by another colonoscopy without PolyDeep (standard technique) | Diagnostic Test: Combination technique First colonoscopy with PolyDeep<br>* Combination technique First colonoscopy with PolyDeep<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma miss rate (AMR) | AMR will be calculated as the number of adenomas detected on the withdrawal or portion in either group divided by the total number of adenomas detected during both withdrawals | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp miss rate | It will be calculated as the number of polyps detected on the withdrawal or portion in either group divided by the total number of polyps detected during both withdrawals | 1 Year | 
| Serrated lesions miss rate | It will be calculated as the number of serrated lesions detected on the withdrawal or portion in either group divided by the total number of serrated lesions detected during both withdrawals | 1 Year | 
| Diagnostic yield and lesions characterization | The diagnostic yield will be measure using sensitivity , specificity, Positive Predictive Value, Negative Predictive Value, likelihood ratios and Youden index. Histological diagnosis will be used as the gold standard. | 1 Year | 
| Withdrawal time. (First/second colonoscopy) | Withdrawal time between the two arms will be calculated and compared. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Adenoma, Colorectal Serrated Lesions, Colorectal Polyps, Computer-Aided polyp Detection (CAD)