Not Yet RecruitingNot Applicable

AI-Assisted MRI Molecular Subtyping in Pediatric Brain Tumors

1,400 participantsStarted 2026-07-15

Plain-language summary

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.

Who can participate

Age range

0 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age younger than 18 years at the time of index surgery. * Evaluated at a participating study center and scheduled for first surgical treatment of a suspected target pediatric brain tumor. * Preoperative brain MRI available before surgery, including at minimum T1-weighted, contrast-enhanced T1-weighted, T2-weighted, and FLAIR sequences in DICOM format; MRI preferably performed within 7 days before surgery and before biopsy or tumor-directed therapy. * Postoperative histopathology confirming one of the following target tumor categories: glioma, medulloblastoma, ependymoma, atypical teratoid/rhabdoid tumor, intracranial germ cell tumors, craniopharyngioma, or choroid plexus tumors. * For the prospective cohort, written informed consent provided by a parent or legal guardian, with child assent obtained when appropriate according to age, understanding, and local ethics requirements. Exclusion Criteria: * Postoperative pathology confirming a non-target tumor type. * Recurrent tumor, repeat surgery, or prior tumor-directed surgery before the index surgery. * Preoperative MRI of inadequate quality for analysis, including severe motion artifact, severe susceptibility/metal artifact, or incomplete field of view. * Prior biopsy, radiotherapy, chemotherapy, or other tumor-directed treatment before the index preoperative MRI that is judged to substantially affect imaging interpretation. * Concurrent malignant disease other than the target brain tumor. * Inability …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area Under the Receiver Operating Characteristic Curve (AUC) for MRI-Based Prediction of Prespecified Molecular Markers

Timeframe: 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

Trial details

NCT IDNCT07703605

SponsorHuashan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2029-12-30

Contact for this trial

Lei Jin

86-21-52887200 ozlei91@126.com

View on ClinicalTrials.gov More Pediatric Brain Tumors trials