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

Sun Yat-sen University

Status: Not yet enrolling

Conditions: Artificial Intelligence Supported Image Reviewing

Treatments: Diagnostic Test: AI

Study type: Observational

Funder types: Other

Identifiers

NCT06356441

B2024-039-01

Details and patient eligibility

About

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.

Enrollment: 10,400 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

10,400 participants in 2 patient groups

AI-supported reading

Description:

The 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.

Treatment:

Diagnostic Test: AI

Standard double reading

Description:

The MR images will be interpreted by two radiologists, and in cases of disagreement, a third radiologist will be consulted to reach a consensus.