Artificial Intelligence-supported Reading Versus Standard Double Reading for the Interpretation of Magnetic Resonance Imaging in the Detection of Local Recurrence for Nasopharyngeal Carcinoma: a Randomised Controlled Multicenter Study

Not yet recruiting

• Conditions: Artificial Intelligence Supported Image Reviewing

• Registration Number: NCT06356441
• Lead Sponsor: Sun Yat-sen University

Brief Summary

The aim of this randomized controlled study is to investigate whether the previously developed artificial intelligence model can triage post-radiotherapy magnetic resonance images of patients with nasopharyngeal carcinoma and assist radiologists in their interpretation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10400

Inclusion Criteria

• Patients with treatment naive nasopharyngeal carcinoma who had finished radiotherapy for 6 months or more
• The previous magnetic resonance imaging examination had showed complete remission in the primary site
• Images are acquired using a 3T magnetic resonance imaging device, including unenhanced T1-weighted and T2-weighted sequences and contrast-enhanced T1-weighted sequences

Exclusion Criteria

• Patients are enrolled in this study for a specific magnetic resonance imaging scan and not for subsequent follow-up magnetic resonance imaging scans.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sensitivity	through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
specificity	through study completion, an average of 2 years
total time of interpretation for all the MR images	through study completion, an average of 2 years
the rate of discussion with a third radiologist	through study completion, an average of 2 years
the sensitivity in the subgroups of different rT-stage	through study completion, an average of 2 years
the incidence of cases whose recurrent risks and contours cannot be provided by the AI model	through study completion, an average of 2 years
the detection rate of local recurrence in the AI-supported reading group	through study completion, an average of 2 years
positive predictive value	through study completion, an average of 2 years
negative predictive value	through study completion, an average of 2 years

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China