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

Sponsor
Fundacin Biomedica Galicia Sur (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05514301
Collaborator
(none)
205
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
17.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
205 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Diagnostic
Official Title:
Polydeep Advance I: Prospective Diagnostic Tests Trial With a Paired Study Design
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sensitivity of Polydeep vs high experienced endoscopists for colorectal polyp detection

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
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.

Outcome Measures

Primary Outcome Measures

  1. Sensitivity of polydeep vs high experienced endoscopist blinded to polydeep [1 year]

    To compare the sensitivity of Polydeep to a high experienced endoscopist for colorectal polyp detection (adenoma or serrated lesion histologically confirmed)

Secondary Outcome Measures

  1. Sensitivity for serrated lesions detection. [1 year]

    To compare the sensitivity of Polydeep to a high experienced endoscopist for serrated lesions detection

  2. Sensitivity for adenoma detection. [1 year]

    To compare the sensitivity of Polydeep to a high experienced endoscopist for adenoma detection

  3. Sensitivity for advanced colonic lesions [1 year]

    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

  4. Sensitivity for diminute lesions (≤5mm) [1 year]

    To compare the sensitivity of Polydeep to a high experienced endoscopist for diminute lesions (≤5mm) detection

  5. To compare the diagnostic yield of the optical diagnosis [1 year]

    To compare diagnostic yield of optic diagnostic of polydeep to high experienced endoscopists.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Complexo Hospitalario Universitario de Ourense Ourense Spain 32002

Sponsors and Collaborators

  • Fundacin Biomedica Galicia Sur

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundacin Biomedica Galicia Sur
ClinicalTrials.gov Identifier:
NCT05514301
Other Study ID Numbers:
  • Polydeep Advance 1.0
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundacin Biomedica Galicia Sur
Colorectal adenomas
Colorectal polyps
Serrated lesions
Computer-Aided detection System (CAD)
Additional relevant MeSH terms:
Colorectal Neoplasms

Study Results

No Results Posted as of Aug 24, 2022