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Clinical Trials/NCT07673692
NCT07673692CompletedNot Applicable

GliomaAI-GBM: Non-Invasive MRI-Based Detection of IDH Wildtype Glioblastoma Using Artificial Intelligence

Deep Learning Institute of Radiological Sciences1 site in 1 country1,372 target enrollmentStarted: March 14, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
1,372
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Deep Learning Institute of Radiological Sciences
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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