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Multicenter Prospective Study on MRI AI Model for Midline Glioma Subtyping and Prognosis:

25. mai 2026 oppdatert av: Xuan Gong, Xiangya Hospital of Central South University

Application of MRI-Based Artificial Intelligence Models for Preoperative Molecular Subtyping and Prognostic Assessment of Midline Gliomas: A Multicenter Prospective Clinical Study

A vision-language model using preoperative MRI and clinical variables has been developed to simultaneously predict three key molecular markers in midline gliomas: H3K27M, IDH, and 1p/19q. This prospective multicenter study will validate the model's accuracy in preoperative molecular subtyping and its value in prognostic assessment and clinical decision-making across multiple neurosurgical centers.

Studieoversikt

Status

Rekruttering

Forhold

Detaljert beskrivelse

This study aims to validate the clinical value of an MRI-based artificial intelligence model for personalized diagnosis and treatment in patients with midline gliomas. The model integrates preoperative MRI features with clinical variables (e.g., age, sex, and other relevant patient characteristics) to predict both molecular subtypes and patient prognosis.

Model workflow. The model takes as input tumor-containing slices from preoperative MRI sequences, along with patient age and sex. By recognizing information within the MRI sequences, the model outputs the predicted molecular diagnosis for the patient.

Primary objective. To evaluate the model's accuracy in preoperative molecular subtyping of midline gliomas (H3K27M, IDH, and 1p/19q status) by comparing its predictions with the gold standard of postoperative or post-biopsy pathology. Diagnostic performance will be assessed using sensitivity, specificity, accuracy, F1 score, and area under the receiver operating characteristic curve (AUC).

Secondary objective. To assess the model's prognostic capability by integrating imaging features with clinical variables to predict patient survival outcomes and treatment response. Prognostic performance will be evaluated using time-dependent AUC and calibration metrics.

Exploratory objective. To explore the model's added value in clinical decision-making, including its potential to guide preoperative treatment planning and risk stratification.

This prospective, multicenter study will be conducted across several tertiary neurosurgical centers in China. The findings are expected to provide high-level evidence supporting non-invasive, precise diagnosis and personalized management of midline gliomas.

Studietype

Observasjonsmessig

Registrering (Antatt)

500

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Gong Xuan, MD.
Telefonnummer: 0086-731-8975-3037
E-post: gong.xuan@csu.edu.cn

Studer Kontakt Backup

Navn: Shuwen Kuang, MD.
Telefonnummer: 0086-13367494221
E-post: 228102171@csu.edu.cn

Studiesteder

Kina
- Hunan
  - Changsha, Hunan, Kina, 410008
    - Rekruttering
    - Xiangya Hospital of Central South University
    - Ta kontakt med:
      
      Shuwen Kuang, MD.
      
      Telefonnummer: 0086-13367494221
      
      E-post: 228102171@csu.edu.cn
    - Ta kontakt med:
      
      Xuan Gong, MD.
      
      Telefonnummer: 0086-731-8975-3037
      
      E-post: gong.xuan@csu.edu.cn

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Barn
Voksen
Eldre voksen

Tar imot friske frivillige

N/A

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients with diffuse gliomas located in the intracranial midline.

Beskrivelse

Inclusion Criteria:

Patients with diffuse gliomas were pathologically and molecularly diagnosed.
The clinical case data of all patients were complete.
Patients underwent preoperative MRI examination.

Exclusion Criteria:

The tumor is not located in the intracranial midline.
Cases in which MRI were incomplete or with significant noise and artifacts.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Diagnostic accuracy for midline glioma molecular subtypes Tidsramme: Perioperative	Model predictions compared with postoperative histopathology and molecular testing (gold standard). Performance metrics include AUC, F1 score, sensitivity, specificity, and accuracy.	Perioperative

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Xiangya Hospital of Central South University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

10. mai 2026

Primær fullføring (Antatt)

31. desember 2030

Studiet fullført (Antatt)

31. desember 2030

Datoer for studieregistrering

Først innsendt

7. mai 2026

Først innsendt som oppfylte QC-kriteriene

25. mai 2026

Først lagt ut (Faktiske)

27. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)