- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07673692
GliomaAI-GBM: MRI-Based Detection of IDH Wildtype Glioblastoma (GliomaAI-GBM)
GliomaAI-GBM: Non-Invasive MRI-Based Detection of IDH Wildtype Glioblastoma Using Artificial Intelligence
The goal of this observational study is to learn whether an artificial intelligence system called GliomaAI-GBM can help detect a specific molecular type of brain tumour called IDH wildtype glioblastoma using routine MRI scans. The study uses previously collected and fully anonymised MRI data from 1,372 patients from 13 institutions in the Cancer Imaging Archive (TCIA).
The main questions it aims to answer are:
- How accurately can GliomaAI-GBM identify IDH wildtype glioblastoma from MRI scans?
- How well does the system perform across data from different hospitals and patient groups?
Researchers will use existing MRI scans and clinical information to train and test the AI system. No new scans, treatments, or hospital visits are required for participants, and all data used is fully anonymised and obtained from an existing research database.
Participants will not be asked to do anything, as this study only uses previously collected imaging data.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mumbai, India
- Deep Learning Institute of Radiological Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult (>=18 years of age)
- Having pre op MRI scan
- Having biopsy / surgery
- Having post biopsy/ surgery histology diagnosis and genetic analysis.
Exclusion Criteria:
- MRI scan significantly degraded by motion or other artefact
- Incomplete genetic analysis
- Prior treatment (e.g., radiotherapy or chemotherapy) before baseline MRI
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic performance of GliomaAI-GBM for identification of IDH wildtype glioblastoma from MRI, measured by accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and area under the ROC.
Time Frame: Perioperative
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The diagnostic performance of the GliomaAI-GBM artificial intelligence model will be assessed by comparing pre-operative MRI-based predictions of IDH wildtype glioblastoma status against post-operative (biopsy or surgery) molecular/genetic profiling results as the reference standard.
Performance metrics including accuracy, sensitivity, specificity, positive predictive value, negative predictive value, and AUC will be calculated.
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Perioperative
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
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
- DLIRS-GLIOMAAI-GBM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Glioma
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University of California, San FranciscoPacific Pediatric Neuro-Oncology ConsortiumRecruitingPediatric Cancer | Low-grade Glioma | Low Grade Glioma of Brain | Recurrent Low Grade GliomaUnited States
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Children's Hospital of PhiladelphiaBlue Earth Diagnostics; Dragon Master FoundationRecruitingGlioma | Low-grade Glioma | Glioma, Malignant | Low Grade Glioma of Brain | Glioma IntracranialUnited States
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Ohio State University Comprehensive Cancer CenterRecruitingWHO Grade 3 Glioma | Recurrent Malignant Glioma | WHO Grade 2 Glioma | Recurrent WHO Grade 3 Glioma | Recurrent WHO Grade 4 Glioma | WHO Grade 4 GliomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI); Food and Drug Administration (FDA)Active, not recruitingRecurrent Glioblastoma | Recurrent Malignant Glioma | Refractory Malignant Glioma | Recurrent WHO Grade III Glioma | Recurrent WHO Grade II Glioma | Refractory Glioblastoma | Refractory WHO Grade II Glioma | Refractory WHO Grade III GliomaUnited States
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Children's Hospital of PhiladelphiaBlue Earth Diagnostics; Dragon Master FoundationRecruitingGlioma | High Grade Glioma | Glioma, Malignant | Diffuse Glioma | Glioma IntracranialUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingGlioblastoma | Malignant Glioma | WHO Grade III Glioma | Recurrent Glioma | Refractory GliomaUnited States
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ChimerixOncoceutics, Inc.TerminatedGlioblastoma | Diffuse Midline Glioma | H3 K27M Glioma | Thalamic Glioma | Infratentorial Glioma | Basal Ganglia GliomaUnited States
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University of California, San FranciscoBeiGene USA, Inc.Active, not recruitingGlioblastoma | Malignant Glioma | Recurrent Glioblastoma | Recurrent WHO Grade III Glioma | WHO Grade III Glioma | IDH2 Gene Mutation | IDH1 Gene Mutation | Low Grade Glioma | Recurrent WHO Grade II Glioma | WHO Grade II GliomaUnited States
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Sabine Mueller, MD, PhDNot yet recruitingGlioblastoma | Diffuse Midline Glioma, H3 K27M-Mutant | High-grade Glioma | High-Grade Glioma (WHO III-IV) | Diffuse Hemispheric Glioma, H3G34 MutantUnited States
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Sabine Mueller, MD, PhDPediatric Neuro-Oncology ConsortiumActive, not recruitingGlioblastoma | Malignant Glioma | Recurrent Glioblastoma | Recurrent Malignant Glioma | Recurrent Grade III Glioma | Grade III GliomaUnited States, Australia
Clinical Trials on GliomaAI-GBM
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Deep Learning Institute of Radiological SciencesCompletedGlioma | Astrocytoma | Astrocytoma, IDH-Mutant, Grade 2 | Astrocytoma, IDH-Mutant, Grade 3 | Astrocytoma, Grade II | Glioma (Diagnosis) | Astrocytoma of BrainIndia
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Deep Learning Institute of Radiological SciencesCompletedGlioma | Astrocytoma | Astrocytoma, Grade IV | Glioma (Diagnosis) | Astrocytoma, IDH-Mutant, Grade 4India
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Deep Learning Institute of Radiological SciencesCompletedGlioma | Oligodendroglioma | 1p19q Codeletion | Glioma (Diagnosis) | IDH-mutant Glioma (Oligodendroglioma, Astrocytoma)India
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Deep Learning Institute of Radiological SciencesCompletedGlioma | Glioblastom WHO Grade 4 | Glioma (Diagnosis)India
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Boston Scientific CorporationRecruitingGlioblastoma Multiforme | Recurrent GlioblastomaUnited States
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University of AlbertaWithdrawnRecurrent Glioblastoma | Glioblastoma - CategoryCanada
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University of FloridaCompletedGlioblastoma Multiforme | Healthy VolunteersUnited States
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VA Office of Research and DevelopmentUniversity of California, Los AngelesNot yet recruiting
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CRISM Therapeutics LTDNot yet recruiting
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Aivita Biomedical, Inc.Active, not recruitingNewly Diagnosed GlioblastomaUnited States