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临床试验/NCT07703761
NCT07703761招募中不适用

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

Università degli Studi di Trento1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2026年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
700
试验地点
1
主要终点
Accuracy, sensitivity, specificity, and AUC of AI models for early glioma detection and classification from MRI, compared to expert evaluation and histological diagnosis.

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: AI-driven analysis of brain MRI data for early, non-invasive detection, segmentation, and histological characterization of gliomas using retrospective clinical and imaging records. (Other)

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Università degli Studi di Trento
申办方类型
Other
责任方
Sponsor

研究点 (1)

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