NCT07703605Toborzás még nem indult
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 23.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 1400 (tervezett)
- Első benyújtás
- 2026. júl. 8.
- Kezdés
- 2026. júl. 15.
- Elsődleges befejezés
- 2029. dec. 30.
- Fő szponzor
- Huashan Hospital
- Betegségek
- Gyermekkori daganatok
- NCT-szám
- NCT07703605
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 1400
- 2026. júl. 15. és az elsődleges befejezés (2029. dec. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
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