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

9. juli 2026 opdateret af: 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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Anslået)

700

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Trento, Italien, 38122
        • Rekruttering
        • CISMed, Centre for Medical Sciences
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Accuracy, sensitivity, specificity, and AUC of AI models for early glioma detection and classification from MRI, compared to expert evaluation and histological diagnosis.
Tidsramme: 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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. januar 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. januar 2031

Datoer for studieregistrering

Først indsendt

9. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

14. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. april 2026

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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