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AI-driven Processing and Analysis of Glioma Imaging Data (GLIOMAID)

9 de julio de 2026 actualizado por: Università degli Studi di Trento

AI-driven Processing and Analysis of Glioma Imaging Data EUCAIM Database Contribution by the Italian Brain Glioma Initiative Italian Title: Elaborazione ed Analisi Supportata Dall'Intelligenza Artificiale di Immagini di Risonanza Magnetica di Gliomi Cerebrali

GLIOMAID is a scientific research project focused on improving how brain tumors, specifically gliomas, are diagnosed and managed. It uses Artificial Intelligence (AI) to analyze MRI brain scans and patient data. The project collects existing clinical information and imaging from glioma patients to build AI models that support doctors in making better and faster treatment decisions.Gliomas, especially high-grade ones, are among the most common and challenging brain tumors. Many patients have poor survival chances, and diagnosis often requires invasive procedures like biopsies.

Despite medical advances, current treatments have limited effectiveness. Better non-invasive diagnostic tools are urgently needed to:

  • Detect tumors earlier.
  • Predict how aggressive they are.
  • Help doctors plan the most effective treatments. The GLIOMAID study aims to reduce the need for invasive diagnostics by creating AI tools that interpret brain scans with high accuracy.

Primary Objectives

  • Create Italy's First Glioma Imaging Database This database will store anonymized MRI scans and clinical records from around 700 patients.
  • Improve Early Detection Develop AI systems to identify brain tumors earlier from MRI scans.
  • Automate Tumor Mapping Use AI to outline tumors on MRI images to assist with surgical planning and treatment follow-up.
  • Non-Invasive Tumor Characterization Train AI models to predict tumor type and severity without needing a biopsy.

Secondary Objectives

  • Study how well AI tools fit into research and future clinical workflows.
  • Test how well AI can predict changes in tumors over time.

Lead Institution: University of Trento and Santa Chiara Hospital, Trento (Prof. Silvio Sarubbo, Principal Investigator).

Partner Hospitals: 7 neurosurgery and neuro-oncology centers across Italy.

Inclusion Criteria

  • Adults aged 18-60 with a confirmed glioma diagnosis (from 2019 to 2024).
  • Patients who had surgical tumor removal, with or without further treatment (e.g., chemotherapy, radiotherapy).
  • MRI scans and basic clinical data must be available.

Exclusion Criteria

  • Poor quality or incomplete MRI scans.
  • Missing essential clinical information.
  • If consent is explicitly refused (when it can be obtained).

Clinical Data

  • Age, sex, diagnosis date.
  • Tumor type and genetic information.
  • Treatments received (surgery, chemo, radiation).
  • Patient outcomes (e.g., survival, tumor progression).

Imaging Data

  • Pre- and post-operative MRI scans (T1, T2, FLAIR).
  • Segmented images highlighting tumor areas and post-surgery cavities.
  • Time points: before surgery, up to 6 months post-op, and during follow-up.

All data is pseudonymized (no personal identifiers) and securely stored.

Expected Results

  • Faster, more accurate diagnosis.
  • More personalized treatment planning.
  • Reduced need for invasive biopsies.

Benefits for Patients and Doctors Patients: Earlier diagnosis, less invasive procedures, better treatment outcomes.

Doctors: Improved decision-making tools, automated image analysis, consistent data for treatment planning.

Descripción general del estudio

Tipo de estudio

De observación

Inscripción (Estimado)

700

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Silvio Sarubbo, MD Spec., PhD
  • Número de teléfono: + 39 0461 903487
  • Correo electrónico: silvio.sarubbo@unitn.it

Ubicaciones de estudio

      • Trento, Italia, 38122
        • Reclutamiento
        • CISMed, Centre for Medical Sciences
        • Contacto:
          • Laura Barin, PhD in biostatistics
          • Número de teléfono: +39 0461 283549
          • Correo electrónico: ricerca.cismed@unitn.it
        • Contacto:
          • Paola Aronica, MSc in Pharmaceutics
          • Número de teléfono: +39 0461 283544
          • Correo electrónico: paola.aronica@unitn.it

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of approximately 700 adult patients (100 per center) aged 18 to 60 years, diagnosed with brain glioma between 2019 and 2024 across seven specialized Italian neurosurgical centers. All participants underwent surgical tumor resection, with or without subsequent radiotherapy or chemotherapy. Only patients with high-quality MRI scans and essential clinical information are included. The study uses retrospective data, and where possible, informed consent is obtained. If consent cannot be collected due to patient death or unreachability, inclusion may still occur under ethically approved conditions. Data are pseudonymized and used to train and validate AI models.

Descripción

Inclusion Criteria:

  • Imaging (MRI) of confirmed glioma diagnosis in the period 2019-2024, for whom cancer types and stages, from diagnosis to post-treatment are available
  • Having undergone a full brain tumor resection operation, followed or not by treatment with RT or CHT
  • Adults aged 18 to 60 years
  • Informed consent available, when possible and applicable

Exclusion Criteria:

  • Poor quality or artifact-laden MRI images
  • Lack of a minimal set of clinical information
  • Explicit refusal of consent (if possible to obtain)
  • Age under 18 years or over 60 years

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Italian Glioma MRI Cohort (2019-2024) for AI-Based Detection and Characterization
This cohort comprises approximately 700 adult patients (aged 18-60) diagnosed with brain gliomas between 2019 and 2024 at seven high-expertise Italian neurosurgical centers. All patients underwent surgical resection, with or without subsequent chemotherapy or radiotherapy. The study collects retrospective clinical data (e.g., diagnosis, treatment history, outcomes) and MRI scans (pre- and post-operative). No new interventions are performed. Instead, the data is used to develop and validate AI models for early tumor detection, automated segmentation, and non-invasive histological characterization.
This intervention is distinguished by its focus on using AI algorithms-specifically convolutional neural networks (CNNs), recurrent neural networks (RNNs), and vision transformers (ViTs)-to analyze retrospective MRI data of glioma patients. Unlike prospective or interventional clinical trials, this study involves no new procedures or treatments; instead, it leverages existing imaging and clinical records to develop non-invasive tools for tumor detection, segmentation, and histological classification.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Accuracy, sensitivity, specificity, and AUC of AI models for early glioma detection and classification from MRI, compared to expert evaluation and histological diagnosis.
Periodo de tiempo: Evaluation performed during the study period using retrospective MRI and clinical data collected from patients diagnosed between 2019 and 2024; AI model development and validation within 24 months.
Evaluation performed during the study period using retrospective MRI and clinical data collected from patients diagnosed between 2019 and 2024; AI model development and validation within 24 months.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

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Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

21 de enero de 2026

Finalización primaria (Estimado)

1 de enero de 2027

Finalización del estudio (Estimado)

1 de enero de 2031

Fechas de registro del estudio

Enviado por primera vez

9 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de julio de 2026

Publicado por primera vez (Actual)

14 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de julio de 2026

Última verificación

1 de abril de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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