- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07703761
AI-driven Processing and Analysis of Glioma Imaging Data (GLIOMAID)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Silvio Sarubbo, MD Spec., PhD
- Phone Number: + 39 0461 903487
- Email: silvio.sarubbo@unitn.it
Study Locations
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Trento, Italy, 38122
- Recruiting
- CISMed, Centre for Medical Sciences
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Contact:
- Laura Barin, PhD in biostatistics
- Phone Number: +39 0461 283549
- Email: ricerca.cismed@unitn.it
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Contact:
- Paola Aronica, MSc in Pharmaceutics
- Phone Number: +39 0461 283544
- Email: paola.aronica@unitn.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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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.
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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.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Ohgaki H. Epidemiology of brain tumors. Methods Mol Biol. 2009;472:323-42. doi: 10.1007/978-1-60327-492-0_14.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Pathological Conditions, Signs and Symptoms
- Disease
- Glioma
- Brain Neoplasms
Other Study ID Numbers
- GLIOMAID
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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