NCT05391477

Artificial Intelligence for Diminutive Polyp Characterization

Efficacy and Cost-effectiveness of an Artificial Intelligence System (GI-Genius) on the Characterization of Diminutive Colorectal Polyps Within a Colorectal Cancer Screening Program: a Multicenter Randomized Controlled Trial (ODDITY Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 643 (estimated)
• Sponsor: Hospital Universitario La Fe · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown.

Detailed description

The resect-and-discard (R\&D) and diagnose-and-leave (D\&L) strategies have been proposed as a means to reduce costs in the evaluation of colorectal polyps avoiding a substantial number of pathology evaluations. A pre-requisite for this paradigm shift is an accurate optical diagnosis (HOD). However, performance results for HOD have been highly variable among endoscopists representing a barrier for the adoption of the R\&D and the D\&L strategies. Artificial intelligence is a promising tool that may have a role in characterizing colon epithelial lesions (CADx), helping to get a reliable optical diagnosis regardless of the endoscopist experience. Performances of the different CADx systems are variable but it seems that, in most cases, high accuracy and sensitivities are achieved. However, these CADx systems have been developed and validated using still pictures or videos, and a real-world accurate test is lacking. No clinical trials have tested this technology in clinical practice and, therefore, performance in real colonoscopies, practical problems, applicability, and cost are unknown. Methods and analysis: The ODDITY trial is a European multicenter randomized, parallel-group superiority trial comparing GI-Genius artificial intelligence optical diagnosis (AIOD) to human optical diagnosis (HOD) of colon lesions ≤ 5 mm performed by endoscopists, using histopathology as the gold standard. A total of 643 patients attending a colonoscopy within a CRC screening program (either FIT- or colonoscopy-based) or because of post-polypectomy surveillance will be randomized to the ADI group or the HOD (control) group. A computer-generated 1:1 blocking randomization scheme stratified for center and endoscopist will be used.

Conditions

• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	GI-Genius artificial intelligence	The software allows for the real-time characterization of framed polyps during a colonoscopy classifying them on adenoma or non-adenoma.

Timeline

• Start date: 2023-02-27
• Primary completion: 2024-05-01
• Completion: 2024-12-01
• First posted: 2022-05-26
• Last updated: 2023-05-31

Locations

1 site across 1 country: Spain