AI-Assisted MRI Molecular Subtyping in Pediatric Brain Tumors

Sponsor
Huashan Hospital
Study ID
NCT07703605
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
0 Years - 17 Years
Healthy Volunteers
Not accepted

Study Details

This multicenter observational cohort study aims to develop and validate an artificial intelligence (AI)-assisted diagnostic system for preoperative molecular subtyping of pediatric brain tumors using routine magnetic resonance imaging (MRI). The study will include seven major pediatric brain tumor categories: glioma, medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor (AT/RT), intracranial germ cell tumors, craniopharyngioma, and choroid plexus tumors. The study includes a retrospective cohort for model development and internal/external validation, and a prospective cohort for further validation. Retrospective data will be collected from pediatric patients who underwent first surgical treatment between January 1, 2020 and December 31, 2025. Prospective enrollment will begin on July 15, 2026, with an anticipated sample size of 150 participants. The AI system will analyze preoperative MRI sequences, including T1-weighted, contrast-enhanced T1-weighted, T2-weighted, and FLAIR images, to predict key molecular markers and integrated diagnostic categories. The primary objective is to evaluate the diagnostic performance of the AI system for prespecified molecular prediction tasks using postoperative histopathology and molecular testing as the reference standard. Secondary objectives include assessing agreement with integrated diagnosis, comparing performance against blinded radiologists, and exploring prognostic associations of AI-predicted subgroups.

Key Dates

First listed
Jul 14, 2026
Start date
Jul 15, 2026
Status verified
Jul 2026
Primary completion
Dec 30, 2029
Completion
Dec 30, 2029

Study Design

Enrollment
1,400 participants (estimated)

Arms

  • Arm: Retrospective Cohort
    Pediatric patients younger than 18 years who underwent first surgical treatment for one of the target brain tumors between January 1, 2020 and December 31, 2025, with available preoperative MRI and postoperative pathological confirmation. Data from this cohort will be used for model development and validation.
  • Arm: Prospective Cohort
    Consecutively enrolled pediatric patients younger than 18 years meeting eligibility criteria from July 15, 2026 onward. Data from this cohort will be used for prospective validation of AI diagnostic performance.

Primary Outcome Measure

Area Under the Receiver Operating Characteristic Curve (AUC) for MRI-Based Prediction of Prespecified Molecular Markers [ Time Frame: Assessed at final model evaluation using all eligible retrospective cases collected from January 1, 2020 through December 31, 2025 and all eligible prospectively enrolled cases with available reference-standard data collected from July 15, 2026 through D ]

Central Contacts

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