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OpenTrials
Completed

NCT Number: NCT07673666

GliomaAI-Astro23: MRI-Based Detection of IDH Mutant Astrocytoma (Grade 2 and 3)

The goal of this observational study is to learn whether an artificial intelligence system called GliomaAI-Astro23 can help detect a specific molecular type of brain tumour called IDH mutant Astrocytoma (grade 2 and 3) 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-Astro23 identify IDH mutant Astrocytoma (grade 2 and 3) 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GliomaAI-Astro23

Device

Software as Medical Device (SaMD) for predicting astrocytoma (grade 2 and 3)

Primary outcomes

  1. Diagnostic performance of GliomaAI-Astro23 for identification of IDH mutant Astrocytoma (grade 2 and 3) 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-Astro23 artificial intelligence model will be assessed by comparing pre-operative MRI-based predictions of IDH mutant Astrocytoma (grade 2 and 3) 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.

Sponsors and collaborators

Lead sponsor

Deep Learning Institute of Radiological Sciences

Other

Registry information

Official study title

GliomaAI-Astro23: Non-Invasive MRI-Based Detection of IDH Mutant Astrocytoma (Grade 2 and 3) Using Artificial Intelligence

Acronym: GliomaAI-A23

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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