Clinical trial NCT05514301: Clinical Validation of Polydeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System
Official title: Polydeep Advance I: Prospective Diagnostic Tests Trial with a Paired Study Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal adenomas
Colorectal polyps
Serrated lesions
Computer-Aided detection System (CAD)
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
name: Ministry of Work and Welfare - Xunta de Galicia
name: Asociación Española de Gastroenterología
name: European Regional Development Fund
First posted: 2022-08-24
Enrollment: 205
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of polydeep vs high experienced endoscopist blinded to polydeep
timeFrame: 1 year
Secondary outcomes:
measure: Sensitivity for serrated lesions detection.
timeFrame: 1 year
measure: Sensitivity for adenoma detection.
timeFrame: 1 year
measure: Sensitivity for advanced colonic lesions
timeFrame: 1 year
measure: Sensitivity for diminute lesions (≤5mm)
timeFrame: 1 year
measure: To compare the diagnostic yield of the optical diagnosis
timeFrame: 1 year
Other outcomes:
Locations:
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
Study officials:
References:
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