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GliomaGLIOMAIDNCT07703761

AI-driven Processing and Analysis of Glioma Imaging Data

An observational study of Glioma and Glioma (Diagnosis), run by Università degli Studi di Trento at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Glioma, Glioma (Diagnosis)
What is being tested?
AI-driven analysis of brain MRI data for early, non-invasive detection, segmentation, and histological characterization of gliomas using retrospective clinical and imaging records.
How many people
700 participants
Where
1 siteItaly
Study dates
21 Jan 2026to 1 Jan 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Silvio Sarubbo, MD Spec., PhD contact

+ 39 0461 903487

silvio.sarubbo@unitn.it

Italy1 site, 1 recruiting
  • CISMed, Centre for Medical Sciences

    Trento, 38122

    Laura Barin, PhD in biostatistics, +39 0461 283549, ricerca.cismed@unitn.it

    Paola Aronica, MSc in Pharmaceutics, +39 0461 283544, paola.aronica@unitn.it

    Recruiting

Other trials in Italy

About this study

Official title: 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:

Read more
  • 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.

Being tested
AI-driven analysis of brain MRI data for early, non-invasive detection, segmentation, and histological characterization of gliomas using retrospective clinical and imaging records.
Keywords
Ai, clinical decision support, MRI, brain tumor, computer-assisted diagnosis, outcome prediction
Medical subject headings
Glioma, Disease, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

    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.

Study groups in NCT07703761
Study groupRoleWhat they receive
Italian Glioma MRI Cohort (2019-2024) for AI-Based Detection and CharacterizationThis 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.
Receives: Other: AI-driven analysis of brain MRI data for early, non-invasive detection, segmentation, and histological characterization of gliomas using retrospective clinical and imaging records.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start21 Jan 2026
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07703761
Sponsor's protocol ID
GLIOMAID
Acronym
GLIOMAID
Status last verified
Apr 2026
First submitted
9 Jul 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tomassini S, Falcionelli N, Bruschi G, Sbrollini A, Marini N, Sernani P, Morettini M, Muller H, Dragoni AF, Burattini L. On-cloud decision-support system for non-small cell lung cancer histology characterization from thorax computed tomography scans. Comput Med Imaging Graph. 2023 Dec;110:102310. doi: 10.1016/j.compmedimag.2023.102310. Epub 2023 Nov 10.

    PubMed 37979340
  • Tomassini S, Falcionelli N, Sernani P, Burattini L, Dragoni AF. Lung nodule diagnosis and cancer histology classification from computed tomography data by convolutional neural networks: A survey. Comput Biol Med. 2022 Jul;146:105691. doi: 10.1016/j.compbiomed.2022.105691. Epub 2022 Jun 6.

    PubMed 35691714
  • Suganyadevi S, Seethalakshmi V, Balasamy K. A review on deep learning in medical image analysis. Int J Multimed Inf Retr. 2022;11(1):19-38. doi: 10.1007/s13735-021-00218-1. Epub 2021 Sep 4.

    PubMed 34513553
  • Ruda R, Angileri FF, Ius T, Silvani A, Sarubbo S, Solari A, Castellano A, Falini A, Pollo B, Del Basso De Caro M, Papagno C, Minniti G, De Paula U, Navarria P, Nicolato A, Salmaggi A, Pace A, Fabi A, Caffo M, Lombardi G, Carapella CM, Spena G, Iacoangeli M, Fontanella M, Germano AF, Olivi A, Bello L, Esposito V, Skrap M, Soffietti R; SINch Neuro-Oncology Section, AINO and SIN Neuro-Oncology Section. Italian consensus and recommendations on diagnosis and treatment of low-grade gliomas. An intersociety (SINch/AINO/SIN) document. J Neurosurg Sci. 2020 Aug;64(4):313-334. doi: 10.23736/S0390-5616.20.04982-6. Epub 2020 Apr 29.

    PubMed 32347684
  • Kotrotsou A, Elakkad A, Sun J, Thomas GA, Yang D, Abrol S, Wei W, Weinberg JS, Bakhtiari AS, Kircher MF, Luedi MM, de Groot JF, Sawaya R, Kumar AJ, Zinn PO, Colen RR. Multi-center study finds postoperative residual non-enhancing component of glioblastoma as a new determinant of patient outcome. J Neurooncol. 2018 Aug;139(1):125-133. doi: 10.1007/s11060-018-2850-4. Epub 2018 Apr 4.

    PubMed 29619649
  • Zigiotto L, Annicchiarico L, Corsini F, Vitali L, Falchi R, Dalpiaz C, Rozzanigo U, Barbareschi M, Avesani P, Papagno C, Duffau H, Chioffi F, Sarubbo S. Effects of supra-total resection in neurocognitive and oncological outcome of high-grade gliomas comparing asleep and awake surgery. J Neurooncol. 2020 May;148(1):97-108. doi: 10.1007/s11060-020-03494-9. Epub 2020 Apr 17.

    PubMed 32303975
  • Sanai N, Berger MS. Glioma extent of resection and its impact on patient outcome. Neurosurgery. 2008 Apr;62(4):753-64; discussion 264-6. doi: 10.1227/01.neu.0000318159.21731.cf.

    PubMed 18496181
  • Capelle L, Fontaine D, Mandonnet E, Taillandier L, Golmard JL, Bauchet L, Pallud J, Peruzzi P, Baron MH, Kujas M, Guyotat J, Guillevin R, Frenay M, Taillibert S, Colin P, Rigau V, Vandenbos F, Pinelli C, Duffau H; French Reseau d'Etude des Gliomes. Spontaneous and therapeutic prognostic factors in adult hemispheric World Health Organization Grade II gliomas: a series of 1097 cases: clinical article. J Neurosurg. 2013 Jun;118(6):1157-68. doi: 10.3171/2013.1.JNS121. Epub 2013 Mar 15.

    PubMed 23495881
  • Chen D, Persson A, Sun Y, Salford LG, Nord DG, Englund E, Jiang T, Fan X. Better prognosis of patients with glioma expressing FGF2-dependent PDGFRA irrespective of morphological diagnosis. PLoS One. 2013 Apr 22;8(4):e61556. doi: 10.1371/journal.pone.0061556. Print 2013.

    PubMed 23630597
  • Brito C, Azevedo A, Esteves S, Marques AR, Martins C, Costa I, Mafra M, Bravo Marques JM, Roque L, Pojo M. Clinical insights gained by refining the 2016 WHO classification of diffuse gliomas with: EGFR amplification, TERT mutations, PTEN deletion and MGMT methylation. BMC Cancer. 2019 Oct 17;19(1):968. doi: 10.1186/s12885-019-6177-0.

    PubMed 31623593
  • Weller M, van den Bent M, Preusser M, Le Rhun E, Tonn JC, Minniti G, Bendszus M, Balana C, Chinot O, Dirven L, French P, Hegi ME, Jakola AS, Platten M, Roth P, Ruda R, Short S, Smits M, Taphoorn MJB, von Deimling A, Westphal M, Soffietti R, Reifenberger G, Wick W. EANO guidelines on the diagnosis and treatment of diffuse gliomas of adulthood. Nat Rev Clin Oncol. 2021 Mar;18(3):170-186. doi: 10.1038/s41571-020-00447-z. Epub 2020 Dec 8.

    PubMed 33293629
  • Ohgaki H. Epidemiology of brain tumors. Methods Mol Biol. 2009;472:323-42. doi: 10.1007/978-1-60327-492-0_14.

    PubMed 19107440
  • Lemee JM, Clavreul A, Menei P. Intratumoral heterogeneity in glioblastoma: don't forget the peritumoral brain zone. Neuro Oncol. 2015 Oct;17(10):1322-32. doi: 10.1093/neuonc/nov119. Epub 2015 Jul 22.

    PubMed 26203067
  • Ius T, Pignotti F, Della Pepa GM, La Rocca G, Somma T, Isola M, Battistella C, Gaudino S, Polano M, Dal Bo M, Bagatto D, Pegolo E, Chiesa S, Arcicasa M, Olivi A, Skrap M, Sabatino G. A Novel Comprehensive Clinical Stratification Model to Refine Prognosis of Glioblastoma Patients Undergoing Surgical Resection. Cancers (Basel). 2020 Feb 7;12(2):386. doi: 10.3390/cancers12020386.

    PubMed 32046132
  • Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.

    PubMed 34185076

Questions about this trial

What is this clinical trial studying?

An observational study of Glioma and Glioma (Diagnosis), run by Università degli Studi di Trento at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Silvio Sarubbo, MD Spec., PhD (+ 39 0461 903487, silvio.sarubbo@unitn.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy, sensitivity, specificity, and AUC of AI models for early glioma detection and classification from MRI, compared to expert evaluation and histological diagnosis. (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07703761, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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