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RecruitingNCT07703761GLIOMAIDUpdated Jul 14, 2026

AI-driven Processing and Analysis of Glioma Imaging Data

An observational study in Glioma and Glioma (Diagnosis), sponsored by Università degli Studi di Trento. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-14.

Sponsored by Università degli Studi di Trento · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
700
Ages
18 Years to 60 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Glioma
  • Glioma (Diagnosis)

Keywords

  • Ai
  • clinical decision support
  • MRI
  • brain tumor
  • computer-assisted diagnosis
  • outcome prediction
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's planned enrollment of 700 is above the median of 88 across 238 observational studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Università degli Studi di Trento is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

Interventions

  • OtherAI-driven analysis of brain MRI data for early, non-invasive detection, segmentation, and histological characterization of gliomas using retrospective clinical and imaging records.

    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.

06

What researchers measure

Primary outcomes

  1. 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.

07

Study locations

1 of 1 sites recruiting
  • CISMed, Centre for Medical Sciences
    Trento, 38122, Italy
    Recruiting
08

References and documents

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 ↗
  • Stupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330. PubMed 15758009 ↗
  • Delgado-Lopez PD, Corrales-Garcia EM. Survival in glioblastoma: a review on the impact of treatment modalities. Clin Transl Oncol. 2016 Nov;18(11):1062-1071. doi: 10.1007/s12094-016-1497-x. Epub 2016 Mar 10. PubMed 26960561 ↗
  • Buckner JC. Factors influencing survival in high-grade gliomas. Semin Oncol. 2003 Dec;30(6 Suppl 19):10-4. doi: 10.1053/j.seminoncol.2003.11.031. PubMed 14765378 ↗
  • Deltour I, Poulsen AH, Johansen C, Feychting M, Johannesen TB, Auvinen A, Schuz J. Time trends in mobile phone use and glioma incidence among males in the Nordic Countries, 1979-2016. Environ Int. 2022 Oct;168:107487. doi: 10.1016/j.envint.2022.107487. Epub 2022 Aug 24. PubMed 36041243 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07703761
Lead sponsor
Università degli Studi di Trento
Responsible party
Sponsor
First posted
Jul 14, 2026
Start date
Jan 21, 2026
Primary completion
Jan 1, 2027 (estimated)
Completion
Jan 1, 2031 (estimated)
Last update
Jul 14, 2026

Study contacts

Silvio Sarubbo, MD Spec., PhD
Contact
silvio.sarubbo@unitn.it
+ 39 0461 903487

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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