NCT07703605Not yet recruiting
AI-Assisted MRI Molecular Subtyping in Pediatric Brain Tumors
AI-Assisted Presurgical MRI Molecular Subtyping for Pediatric Brain Tumors: A Single-Center Ambispective Clinical Cohort Study
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 8 Jul 2026
- Start date
- 15 Jul 2026
- Primary completion date
- 30 Dec 2029
- Lead sponsor
- Huashan Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT07703605
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 15 Jul 2026 to the primary completion date, 30 Dec 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recurrent tumor, repeat surgery, or prior tumor-directed surgery before the index surgery.
- 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.
Other
- Postoperative pathology confirming a non-target tumor type.
- Preoperative MRI of inadequate quality for analysis, including severe motion artifact, severe susceptibility/metal artifact, or incomplete field of view.
- Inability to comply with follow-up requirements in the prospective cohort, in the investigator's judgment, because of severe comorbidity or other practical limitations.
Who the study is looking for
- 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.
Age in the registry: 0 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.