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

NCT ID: NCT06356441

Last Updated: 2024-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

10400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-30

Study Completion Date

2026-04-30

Brief Summary

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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

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Conditions

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Artificial Intelligence Supported Image Reviewing

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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AI-supported reading

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.

AI

Intervention Type DIAGNOSTIC_TEST

An artificial intelligence model predicts the risk and contours of local recurrence for MR images and triages them before radiologists interpret them.

Standard double reading

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

No interventions assigned to this group

Interventions

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AI

An artificial intelligence model predicts the risk and contours of local recurrence for MR images and triages them before radiologists interpret them.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Fang-Yun Xie

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fang-Yun Xie

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Central Contacts

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Fang-Yun Xie

Role: CONTACT

+8602087342926

Pu-Yun OuYang

Role: CONTACT

+8602087342926

Facility Contacts

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Fang-Yun Xie

Role: primary

+8602087342926

Pu-Yun OuYang

Role: backup

+8602087342926

References

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OuYang PY, He Y, Guo JG, Liu JN, Wang ZL, Li A, Li J, Yang SS, Zhang X, Fan W, Wu YS, Liu ZQ, Zhang BY, Zhao YN, Gao MY, Zhang WJ, Xie CM, Xie FY. Artificial intelligence aided precise detection of local recurrence on MRI for nasopharyngeal carcinoma: a multicenter cohort study. EClinicalMedicine. 2023 Aug 30;63:102202. doi: 10.1016/j.eclinm.2023.102202. eCollection 2023 Sep.

Reference Type BACKGROUND
PMID: 37680944 (View on PubMed)

Other Identifiers

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B2024-039-01

Identifier Type: -

Identifier Source: org_study_id

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