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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
Interventions
Diagnostic Test: AI
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

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
Arm && Interventions
GroupInterventionDescription
AI-supported readingAIThe AI model predicts the incidence of local recurrence. If the incidence is below 60%, one radiologist will interpret the MR images. If the incidence is above 60%, two radiologists will interpret the MR images. The radiologists will be provided with the predictive incidence and contours in their interpretation if desired. If two radiologists provide contradictory interpretations, a third radiologist will participate in the discussion to reach a consensus.
Primary Outcome Measures
NameTimeMethod
sensitivitythrough study completion, an average of 2 years
Secondary Outcome Measures
NameTimeMethod
total time of interpretation for all the MR imagesthrough study completion, an average of 2 years
the rate of discussion with a third radiologistthrough study completion, an average of 2 years
the sensitivity in the subgroups of different rT-stagethrough study completion, an average of 2 years
the incidence of cases whose recurrent risks and contours cannot be provided by the AI modelthrough study completion, an average of 2 years
negative predictive valuethrough study completion, an average of 2 years
the detection rate of local recurrence in the AI-supported reading groupthrough study completion, an average of 2 years
positive predictive valuethrough study completion, an average of 2 years
specificitythrough study completion, an average of 2 years

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center

🇨🇳

Guangzhou, Guangdong, China

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